| Drugs | Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) | All lots | Class I | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient. | Fabscout Entertainment, Inc |
| Drugs | Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language) | All lots | Class I | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient. | Fabscout Entertainment, Inc |
| Veterinary | PURINA TEST DIET: Mod PicoLab Mouse w/12 PPM Ivermectin Route of Administration: Oral; Name and Address: Richmond Indiana Test Diet, 1050 Progress Drive, Richmond, IN 47374; Product Code 5D5R | Lot number:13JUL19RTD1 | Class I | A single lot (one 3.065 kg lot) test diet product Mod PicoLab Mouse w/12 ppm Ivermectin was manufactured incorrectly. The Test Diet facility was advised by their customer of a rodent mortality incident and the on-site veterinarian diagnosed Ivermectin toxicity. Investigation confirmed that an employee manufacturing error resulted in a significantly elevated level of Ivermectin in this feed. | Land O Lakes Purina LLC |
| Drugs | Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30. | Lot 25-220-DD, Exp 1JAN2015 | Class I | Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored. | Hospira Inc. |
| Devices | Dental Abutment labeled in part: "4555 Riverside Drive Palm Beach Gardens, FL 33410 USA 1-800-342-5454***EDAZ , EDAZx and ILDExxx***BellaTek Zirconia Abutment Position Number: XX Abutment; Pilier; Abutment; Abutment; Pilastro; Pilar***Rx only***Non-sterile, Sterilize prior to use.***Biomet 3i Dental Iberica S.L.*** Biomet 3i Dental Abutments are intended for use as accessories to endosseous dental implants to support prostheses in edentulous or partially edentulous patients. These are intended for use to support single and multiple tooth prostheses. | All lots of products made since April 1, 2011. Catalog model EDAZ, EDAZx and ILDExxx | Class II | Reports relating to Biomet 3i's BellaTek Zirconia Dental Abutment fractures were received. | Biomet 3i, LLC |
| Food | 10" Chocolate Supreme Cake Layers, NET WT. 20 oz. packed in cases of 12. Keep Frozen until ready to use. CSM Bakery Products NA, Inc., Tucker, GA 30084 USA Product is for institutional use. | Lot #1328702013 All cases stamped with Lot #1328702013 and also showing a USE BY date of JUL/14/14 along with a 24-hour time stamp between 15:00 and 24:00. For example, a case showing "1328702013 17:36 USE BY JUL/14/14" is subject to the recall while "1328702013 02:14 USE BY JUL/14/14" is not subject to the recall. Also NOT included in the recall would be a case showing an earlier USE BY date along with Lot # 1328702013. For example, "1328702013 15:36 USE BY JUL/13/14" is not subject to the recall. | Class II | Foreign Material - specifically the product has the potential to contain pieces of a red plastic scoop. | CSM Bakery Products North America |
| Drugs | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38. | Lot #: P285288, Exp 11/13 | Class I | Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution. | Baxter Healthcare Corp. |
| Drugs | 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. | Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14 | Class I | Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution. | Baxter Healthcare Corp. |
| Drugs | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04. | Lot#: P287045, Exp 6/2014 | Class I | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. |
| Drugs | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04. | Lot#: P275883, Exp 10/2013 | Class I | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. |
| Drugs | Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04. | Lot# P285122, Exp 5/2014 | Class I | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. |
| Food | Good Neighbors Specialty Foods Tabouli Salad; 8 oz plastic container; UPC 18561500007 and 14 oz plastic container; 18561500068 | B339 | Class II | Customer found blade inside the salad. | Good Neighbors Specialty Foods, LLC |
| Biologics | Red Blood Cells Leukocytes Reduced | W042013052033C | Class III | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | Blood Systems, Inc. DBA United Blood Services |
| Devices | ENDOBON XENOGRAFT GRANULES 0.5 ML (Bovine bone substitute) Endobon is a bone substitute of bovine origin formed from ceramised bone for implantation or transplantation when bone is lost due to trauma or requested during reconstructive surgery. | Model # ROX05, Batch # S0171051 | Class III | Individual pieces of a batch of Biomet's Endobon Xenograft Granules 0.5 ML (Bovine Bone substitute) may have an incorrect label with the wrong batch number. | Biomet 3i, LLC |
| Devices | VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated | Lot 9052-0045-6358, expiry date 01 Aug 2015 | Class II | An incorrect assay value (0.3785) was printed on the product carton for the 460 nm wavelength (filter) that may cause a delay in the ability to obtain and report TBIL, Bu, Bc, and derived tests results. The correct assay value is 0.8658. | Ortho-Clinical Diagnostics |
| Biologics | Red Blood Cells Leukocytes Reduced | W053513021187 | Class III | Blood product, which did not meet acceptable product specifications, was distributed. | Central Jersey Blood Center, Inc. |
| Biologics | Red Blood Cells | W036811129421 | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | OneBlood, Inc. |
| Biologics | Blood and Blood Products for Reprocessing | W036811129421 | Class III | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | OneBlood, Inc. |
| Biologics | Platelets Pooled Leukocytes Reduced | W036813807738 | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. | OneBlood, Inc. |
| Biologics | Fresh Frozen Plasma | W036813120047 | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed | OneBlood, Inc. |
| Biologics | Red Blood Cells Leukocytes Reduced | W036813120047 | Class II | Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed | OneBlood, Inc. |
| Biologics | Cryoprecipitated AHF, Pooled | W333613056988 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | Mississippi Valley Reg Bld Ctr |
| Biologics | Blood and Blood Products for Reprocessing | W333613055388; W333612069481 | Class II | Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. | Mississippi Valley Reg Bld Ctr |
| Biologics | Source Plasma | 0700212145 | Class II | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. | Biomat USA, Inc |
| Biologics | Red Blood Cells Leukocytes Reduced | W036813160797 | Class II | Blood product, mislabeled as to antigen phenotype, was distributed. | OneBlood, Inc. |
| Biologics | Blood and Blood Products for Reprocessing | 002K50984 | Class III | Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. | American Red Cross Blood Services |
| Biologics | Red Blood Cells | 2522469 | Class II | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. | OneBlood, Inc. |
| Biologics | Cryoprecipitated AHF | 2522469 | Class II | Blood products, collected from a donor for whom donor suitability was not adequately determined, were distributed. | OneBlood, Inc. |
| Biologics | Red Blood Cells Leukocytes Reduced | W702113004590 | Class II | Blood product, which did not meet the acceptable product specifications, was distributed. | Southern California Permanente Medical Group |
| Biologics | Blood and Blood Products for Reprocessing | 02K50984 | Class III | Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. | American Red Cross Blood Services |
| Biologics | Platelets Pooled Leukocytes Reduced | W044114003315 | Class II | Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. | LifeServe Blood Center |
| Biologics | Red Blood Cells | W038113338931 | Class II | Blood products, routine testing/testing performed, interpreted, or documented incorrectly, was distributed. | OneBlood, Inc. |
| Biologics | Cryoprecipitated AHF, Pooled | W038113986219; W038113986203; W038113986180; W038113986151; W038113986204 | Class III | Blood products, not manufactured in accordance to current Good Manufacturing Practices, were distributed. | OneBlood, Inc. |
| Devices | Buzzaround XL scooters' Product Usage: mobility | GB 116 and GB146 series, with multiple serial numbers | Class II | Buzzaround XL scooters' front to rear lockup can become unintentionally disengaged due to possible improper fit of the front alignment cup to the rear alignment screw. | Golden Technologies, Inc. |
| Biologics | Platelets Pheresis Leukocytes Reduced | W158013703093; W158013703093; W158013703093; W158013703098; W158013703105; W158013703105; W158013703109; W158013703109; W158013703115; W158013703115; W158013703119; W158013703119; W158013703124; W158013703131; W158013703139; W158013703139; W158013703144; W158013703144; W158013703148; W158013703153; W158013703155; W158013703155; W158013703159; W158013703164; W158013703168; W158013703168; W158013703168; W158013703170; W158013703175; W158013703179; W158013703179; W158013703188; W158013703189; W158013703189; W158013703194; W158013703195 | Class II | Blood products, which did not meet the acceptable product specifications, were distributed. | Arup Laboratories, Inc. |
| Drugs | Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831*** | Lot number: 12052013:03 Expiration date: 06/03/2014 | Class II | Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping | RX South LLC DBA RX3 Pharmacy |
| Food | Item number T3695, White cheddar jalapeno seasoning powder, 50 lb bags. | Lots 34577 and 40257 | Class I | All American Seasonings is recalling T3695 White cheddar jalapeno seasoning powder, lots 34577 and 40257 after being notified by Elite spice that there was a potential recall for salmonella in the Jalapeno powder they received. | All American Seasonings |
| Devices | FreeStyle Blood Glucose Monitors System. For in vitro diagnostic use only. Store at room temperature below 86 degrees F (30 degrees C). Use test strips only within the system operating temperature range as outlined in your Owner's Booklet. Meter made in China; Distributed by Abbott Diabetes Care, Alameda, CA The FreeStyle mete should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Mete can product inaccurate results. The FreeStyle Glucose meter is incorporated into the OmniPod insulin Management system (manufactured by Insulet Corporation, Bedford, MA and is intended for subcutaneous delivery of insulin. Intended to monitor blood glucose from samples taken from the body. IVD use only, | Part number CAT11001-0; all serial numbers | Class I | Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry. | Abbott Diabetes Care, Inc. |
| Devices | FreeStyle Flash Blood Glucose Monitors System. Meter made in China; Distributed by TheraSense, Alameda, CA The FreeStyle Flash meter should only be used with FreeStyle Test Strips and FreeStyle Control Solution. Using other brands of test strips and control solutions with the FreeStyle Meter can product inaccurate results. Intended to monitor blood glucose from samples taken from the body. IVD use only, | Catalog Number 17002 NDC 99073-0170-02. All serial numbers | Class I | Abbott Diabetes Care has identified through internal testing and investigation that all non-applied voltage legacy meters have the potential to produce out of range control solution results and/or erroneously low blood glucose results when used in conjunction with Free Style test strips lots within expiry. | Abbott Diabetes Care, Inc. |
| Food | FLOUR TORTILLAS: FAJITA 6" 15 0Z UPC Code 1569602222, HOMESTYLE 8" 24 OZ UPC Code 1569602221, BURRITO 10" 28OZ UPC Code 1569602223, GRANDE 12" 36 OZ UPC Code 1569602224, JUAREZ 8" 24 OZ UPC Code 1569603337, 8" RESTAURANT 23 OZ UPC Code 1569602230, 10" RESTAURANT 28 OZ UPC Code 1569602226. Packaged in clear poly plastic bags. | Expiration Dates from December 20 to February 27, 2014 | Class II | Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 due to metal detector malfunction during production and therefore potential for metal in product. | Tortillas Mexico Mexico, Incorporated |
| Food | CORN TORTILLAS: 18 CT YELLOW/WHITE 18 OZ USPC Code 1569603333, 36 COUNT YELLOW/WHITE 36 OZ USPC Code 1569603335/4, 75 COUNT WHITE CORN 5 LB,USPC Code 1569603331, 100 COUNT WHITE CORN 100 OZ USPC Code 1569603336, 36 COUNT MINI 24 OZ USPC Code 1569603332, 36 COUNT TAQUITO 23 OZ UPC Code 1569603345, 100 COUNT TAQUITO 4 LB UPC Code 1569603346. Packaged in clear poly plastic bags. | Expiration Dates from December 20 to February 27, 2014 | Class II | Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 because a meatal staple was found by a consumer in a baked tortilla. Investigation by the Colorado Health Department found the firm's metal detector was not functioning. | Tortillas Mexico Mexico, Incorporated |
| Food | WHEAT TORTILLAS: 9 COUNT, 18 OZ, UPC Code 1569602225. Packaged in clear poly plastic bags. | Expiration Dates from December 20 to February 27, 2014 | Class II | Tortillas Mexico is recalling all tortillas with the Expiration Dates from December 20 to February 27, 2014 because a meatal staple was found by a consumer in a baked tortilla. Investigation by the Colorado Health Department found the firm's metal detector was not functioning. | Tortillas Mexico Mexico, Incorporated |
| Devices | Gibralt Spine System Polyaxial Screw Intended to promote fusion of the cervical spine, and the thoracic spine, (C3-T3), the Gibralt Spinal System is indicated for the following: DDD (neck pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, spinal stenosis, fracture, dislocation, failed previous fusion and/or tumors. The hooks and rods are also intended to provide stabilization to promote fusion following reduction of fracture/dislocation or trauma in the cervical/upper thoracic (C3-T3) spine. | size 3.5mm x 10mm, Catalog #05-000-20-3510, Lot Number #35917001. size 3.5mm x 14mm, Catalog #05-000-20-3514, Lot Number 35917002 and 40023002. size 3.5mm x 20mm, Catalog #05-000-20-3520, Lot Number 35917003. size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917004. size 4.0mm x 14mm, Catalog #05-000-20-4014, Lot Number 35917005. size 4.0mm x 20mm, Catalog #05-000-20-4020, Lot Number 35917006. size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917007. 1/4 Shank, size 3.5mm x 26mm, Catalog #05-000-20-3526, Lot Number 35917008. 1/4 Shank, size 3.5mm x 30mm, Catalog #05-000-20-3530, Lot Number 35917009. 1/4 Shank, size 4.0mm x 26mm, Catalog #05-000-20-4026, Lot Number 35917010. 1/4 Shank, size 4.0mm x 30mm, Catalog #05-000-20-4030, Lot Number 35917011. | Class II | The products have been identified to contain springs which have been manufactured with type-304 stainless steel rather than the specified titanium alloy. | Exactech, Inc. |
| Devices | Gender Solutions" Natural-Knee® Flex System: N-K FLEX MBACK SZ 0 PAT N-K FLEX MBACK SZ 1 PAT N-K FLEX MBACK SZ 2 PAT | Item Numbers 00541800000 00541800001 00541800002 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Natural-Knee® N-K II DOMED ALL-POLY PAT, SZ0 N-K II DOMED ALL-POLY PAT, SZ1 | Item Number 00591101128 00591101137 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | MOST Options" System (MOST) HINGED TIB INS SZ 1 16MM HINGED TIB INS SZ 4 6MM M HINGED TIB INS SZ 4 9MM M HINGED TIB INS SZ 4 16MM MOST PROX TIB INS 6MM | Item Number 502001016 502004006 502004009 502004016 502010006 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Natural-Knee® II - Unicompartmental Knee Prosthesis: CONG TIB INS SZ1/2 9MM UN CONG TIB INS SZ1/2 11MM U CONG TIB INS SZ1/2 13MM U CONG TIB INS SZ3/4 9MM UN CONG TIB INS SZ3/4 11MM U CONG TIB INS SZ3/4 13MM U CONG TIB INS SZ 5/6 9MM U CONG TIB INS SZ5/6 11MM U CONG TIB INS SZ5/6 13MM U | Item Number 611001009 611001011 611001013 611002009 611002011 611002013 611003009 611003011 611003013 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Natural-Knee® II Unicompartmental Knee System: UNI ALL-POLY TIB SZ 1-7mm UNI ALL-POLY TIB SZ 1-9mm | Item Number 613001007 613001009 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Natural-Knee®/Apollo" Knee: M/B PAT SZ0 NATURAL-KNEE M/B PAT SZ1 NATURAL-KNEE M/B PAT SZ2 NATURAL-KNEE | Item Number 620001100 620001101 620001102 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Natural-Knee® Congruent Tibial Insert with Screw: SF-CON TIB INS LT SZ1/2 1 SF-CON TIB INS RT SZ1/2 9 SF-CON TIB INS RT SZ3/4/5 | Item Number 620005819 620005909 620006916 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Natural-Knee® II System ULTRA CONG INS LT SZA/9MM ULTRA CONG INS LT SZA/13M ULTRA CONG INS LT SZA/19M ULTRA CONG INS RT SZA/9MM ULTRA CONG INS RT SZA/11M ULTRA CONG INS RT SZA/13M ULTRA CONG INS RT SZA/19M ULTRA CONG INS LT SZB/13M ULTRA CONG INS LT SZB/16M ULTRA CONG INS RT SZB/19M ULTRA CONG INS RT SZB/22M NKII ROT PLTFM U/C INS, 9 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 NKII ROT PLTFM U/C INS, 1 ALL POLY CONG TIB LT SZ00 ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB LT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB RT SZ0/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB LT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB RT SZ1/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB LT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB RT SZ2/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB LT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB RT SZ3/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB LT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ4/ ALL POLY CONG TIB RT SZ5/ PS TIB INS RT SZ1/2 16MM PS TIB INS RT SZ1/2 19MM PS TIB INS LT SZ00/0 19MM PS TIB INS RT SZ00/0 11MM PS TIB INS RT SZ00/0 16MM | Item Number 625001609 625001613 625001619 625001709 625001711 625001713 625001719 625002613 625002616 625002719 625002722 630809510 630811410 630811510 630813410 630813510 630816210 630816410 630816510 630819010 630819110 630819210 630819310 630819410 630819510 635000009 635001009 635001011 635001111 635001116 635002009 635002011 635002109 635002111 635002113 635003009 635003011 635003013 635003016 635003109 635003113 635003116 635004009 635004011 635004016 635004111 635004113 635004119 635005013 635005019 635005111 635005116 635006109 670501916 670501919 670503819 670503911 670503916 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Natural-Knee® II Constrained Knee System NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ3-5 -R NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ1/2-LF NKII CCK TIB INS SZ3-5 -L NKII CCK TIB INS SZ00/0-R NKII CCK TIB INS SZ1/2-RT NKII CCK TIB INS SZ00/0-L NKII CCK TIB INS SZ00/0-R | Item Number 672009100 672009101 672009103 672009200 672009203 672011101 672011103 672011200 672011201 672011203 672013100 672013101 672013103 672013200 672013203 672016101 672016103 672016200 672016203 672019100 672019101 672019200 672019201 672022101 672022103 672022200 672022201 672025100 672025200 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Natural-Knee® II Posterior Stabilized (P.S.) Condylar Tibial Inserts: N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS INS TIB SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ N-K II CONS PS TIB INS SZ | Item Number 672509100 672509101 672509200 672509203 672511100 672511103 672513101 672513103 672513201 672516103 672519103 672522201 672525103 672525203 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Apollo" Knee System: APOLLO PATELLA SZ0 28MM R | Item Number 680001000 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Apollo Knee Tibial Baseplate/Knee Tibial Insert: CONG TIB INS SZ0/19MM APO CONG TIB INS SZ0/22MM APO CONG TIB INS SZ1/9MM APOL CONG TIB INS SZ1/11MM APO CONG TIB INS SZ1/19MM APO CONG TIB INS SZ2/13MM APO CONG TIB INS SZ2/19MM APO CONG TIB INS SZ3/9MM APOL CONG TIB INS SZ3/13MM APO | Item Number 681100019 681100022 681101009 681101011 681101019 681102013 681102019 681103009 681103013 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Apollo" Knee System: PS TIB INS SZ0/16MM APOLL PS TIB INS SZ0/19MM APOLL PS TIB INS SZ0/22MM APOLL PS TIB INS SZ1/16MM APOLL PS TIB INS SZ2/16M APOLLO PS TIB INS SZ2/22MM APOLL PS TIB INS SZ3/16MM APOLL PS TIB INS SZ3/19MM APOLL PS TIB INS SZ4/9MM APOLLO PS TIB INS SZ4/11MM APOLL PS TIB INS SZ4/13MM APOLL PS TIB INS SZ4/16MM APOLL PS TIB INS SZ4/19MM APOLL PS TIB INS SZ4/22MM APOLL PS TIB INS SZ5/9MM APOLLO PS TIB INS SZ5/19MM APOLL | Item Number Item Number 681600016 681600019 681600022 681601016 681602016 681602022 681603016 681603019 681604009 681604011 681604013 681604016 681604019 681604022 681605009 681605019 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Apollo" Revision/Constrained Knee System: SZ0-16MM AK CCK TIB INSER SZ1-11MM AK CCK TIB INSER SZ1-16MM AK CCK TIB INSER SZ1-22MM AK CCK TIB INSER SZ1-30MM AK CCK TIB INSER SZ2-11MM AK CCK TIB INSER SZ2-13MM AK CCK TIB INSER SZ2-16MM AK CCK TIB INSER SZ2-22MM AK CCK TIB INSER SZ2-30MM AK CCK TIB INSER SZ3-16MM AK CCK TIB INSER SZ3-22MM AK CCK TIB INSER SZ3-25MM AK CCK TIB INSER SZ4-13MM AK CCK TIB INSER SZ4-16MM AK CCK TIB INSER SZ5-11MM AK CCK TIB INSER | Item Number 682000016 682001011 682001016 682001022 682001030 682002011 682002013 682002016 682002022 682002030 682003016 682003022 682003025 682004013 682004016 682005011 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Natural-Knee® II System: POLY ULTRA TIB LT SZ00/9M POLY ULTRA TIB LT SZ0/9MM POLY ULTRA TIB LT SZ0/19M POLY ULTRA TIB RT SZ0/13M POLY ULTRA TIB RT SZ0/16M ALL POLY ULTRA TIB LT SZ1 ALL POLY ULTRA TIB RT SZ1 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB LT SZ2 ALL POLY ULTRA TIB RT SZ2 ALL POLY ULTRA TIB LT SZ3 ALL POLY ULTRA TIB RT SZ3 ALL POLY ULTRA TIB RT SZ5 | Item Number 621800809 621801809 621801819 621801913 621801916 621810816 621810909 621820809 621820811 621820911 621830811 621830909 621850916 | Class II | A complaint was received for a discolored All Poly Tibia. Root cause analysis found that the discoloration was the result of free radical oxidation. The oxidation process was advanced prematurely as a result of the machined component being stored in a transparent container exposed to artificial light for six years prior to inert packaging and sterilization of the device. | Zimmer, Inc. |
| Devices | Mar Cor Purification Millenium HX Portable Reverse Osmosis System. Model 3025975. Product Usage: Water Purification System is intended to be used as a dialysis accessory to produce water through reverse osmosis for use with hemodialysis equipment.. | Serial Numbers: 1294627, 1298383, 1298386, 1299352, 1299353, 1299354, 1299355, 1299356, 1299486, 1299487, 1299488, 1299489, 1299503, 1299572, 1299712, 1299713, 1299716, 1299718, 1299719, 1299720, 1299740, 1299742, 1299777, 1299779, 1299780, 1299831, 1299835, 1299850, 1299867, 1299868, 1299895, 1299897, 1299992, 1299993, 1299994, 1299996, 1299997, 1300138, 1300224, 1300248, 1300363, 1300364, 1300367, 1300368, 1300558, 1300560, 1300561, 1300562, 1300564, 1300565, 1300621, 1300649, 1300650, 1300700, 1300701, 1301081, 1301116, 1301360, 1301361, 1301386, 1301888, 1301990, 1301992, 1301997, 1302030, 1302032, 1302149, 1302214, 1302226, 1302342, 1302345, 1302346, 1302385, 1302430, 1302447, 1302448, 1302452, 1302456, 1302464, 1302517, 1302555, 1302558, 1302642, 1302696, 1302706, 1302708, 1302748, 1302767, 1302768, 1302810, 1302813, 1302922, 1302923, 1302924, 1302925, 1302926, 1302927, 1302987, 1303005, 1303108, 1303315, 1303316, 1303346, 1303348, 1303351, 1303352, 1303505, 1303516, 1303532, 1303533, 1303534, 1303557, 1303558, 1303625, 1303626, 1303689, 1303690, 1303693, 1303702, 1303711, 1303768, 1303781, 1303799, 1303806, 1303821, 1303872, 1303877, 1303908, 1303920, 1303975, 1303976, 1304070, 1304076, 1304077, 1304081, 1304163, 1304166, 1304167, 1304170, 1304173, 1304174, 1304194, 1304196, 1304203, 1304273, 1304293, 1304294, 1304297, 1304333, 1304340, 1304343, 1304344, 1304346, 1304349, 1304376, 1304381, 1304501, 1304502, 1304503, 1304507, 1304508, 1304551, 1304585, 1304587, 1304724, 1304725, 1304775, 1304778, 1304779, 1304829, 1304870, 1304902, 1304903, 1304929, 1305006, 1305007, 1305038, 1305040, 1305041, 1305087, 1305088, 1305089, 1305131, 1305133, 1305210, 1305238, 1305239, 1305355, 1305363, 1305608, 1305609, 1305650, 1305651, 1305655, 1305698, 1305700, 1305701, 1305717, 1305732, 1305735, 1305750, 1305751, 1305752, 1305795, 1305928, 1305931, 1305932, 1305975, 1305995, 1306007, 1306042, 1306046, 1306078, 1306125, 1306154, 1306178, 1306209, 1306215, 1306226, 1306259, 1306322, 1306341, 1306428, 1306429, 1306430, 1306431, 1306432, 1306654, 1306662, 1306663, 1306664, 1306665. | Class II | High inlet water pressure beyond specification and the solenoid valve does not meet application which could result in a delay in treatment. | Mar Cor Purification |
| Devices | Denlase: Diode Laser Therapy System and Penlase: Dental Laser Therapy System surgical powered. Surgical powered Laser instruments. | Denlase and Penlase Dental Laser Systems. | Class II | Failure to provide calibration procedures to purchasers, as required by 21 CFR 1040.11(a)(2). For example, the user manual did not contain calibration procedures for Denlase or Penlase Lasers | China Daheng Group Inc. |
| Devices | Product Brand Name(s): Alere Triage® TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56035B. 25 individually pouched devices in a labeled kit box. Indications for use: The Alere Triage® TOX Drug Screen is a fluorescence immunoassay to be used with the Alere Triage® Meters for the qualitative determination of the presence of drug and/or the major metabolites above the threshold concentrations of up to 10 distinct drug classes, including assays for acetaminophen/paracetamol, amphetamines, methamphetamines, barbiturates, benzodiazepines, cocaine, methadone, opiates, phencyclidine, THC and tricyclic antidepressants in urine. The acetaminophen/paracetamol assay will yield positive results when acetaminophen/paracetamol is ingested at or above therapeutic doses. This test provides only a preliminary result. Clinical consideration and professional judgment must be applied to any drug of abuse test result, particularly in evaluating a preliminary positive result. In order to obtain a confirmed analytical result, a more specific alternate chemical method is needed. Gas Chromatography/Mass Spectrometry (GC/MS), Liquid Chromatography/ Mass Spectrometry/ Mass Spectrometry (LC/MS/MS) and High Performance Liquid Chromatography (HPLC) are common confirmatory methods. A quantitative serum acetaminophen/paracetamol measurement is the common confirmatory method for preliminary positive acetaminophen/paracetamol results. | Catalog Number 94400, Lots W56013B and W56035B | Class II | Alere San Diego, Inc. is initiating a recall of the Alere Triage® TOX Drug Screen, Catalog Number 94400, Lots W56013B and W56035B because Alere's investigation has shown that these lots have a frequency of false negative results for PCP (Phencyclidine) that is higher than the frequency shown in the package insert. If you have questions about previously reported results. | Alere San Diego, Inc. |
| Biologics | Source Plasma | TT0306091; TT0307155; TT0307638; TT0305128; TT0305458 | Class II | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. | DCI Biologicals Temple Terrace, LLC |
| Biologics | Source Plasma | TT0332120; TT0332466; TT0332926; TT0298638; TT0299019; TT0299579; TT0300059; TT0302035; TT0302785; TT0303087; TT0303804; TT0310875; TT0311187; TT0319719; TT0320023; TT0320584; TT0321162; TT0321623; TT0322549; TT0322679; TT0323400; TT0323655; TT0324230; TT0324464; TT0325344; TT0325718; TT0326545; TT0326954; TT0327595; TT0327837; TT0328375; TT0328664; TT0329243; TT0329742; TT0330045; TT0330481; TT0330841; TT0331263; TT0331645 | Class II | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. | DCI Biologicals Temple Terrace, LLC |
| Biologics | Source Plasma | BY0386092; BY0386376; BY0387157; BY0387287; BY0387767; BY0387954; BY0388378 | Class III | Blood products, collected from a donor who was previously deferred, were distributed. | DCI Biologicals, LLC |
| Biologics | Source Plasma | TT0297450; TT0297848; TT0298354; TT0298821 | Class II | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. | DCI Biologicals Temple Terrace, LLC |
| Devices | syngo Dynamics Picture Archiving and Communication System (PACS). Model numbers 10091804, 10091805, 10091806, 10091807, 10091673 | Model nos.10091804, 10091805, 10091806, 10091807, 10091673. syngo Dynamics Version 9.5 using Sensis integration. | Class II | Potential patient data mixup. Improper error handling could allow for two different patients to be displayed in syngo Dynamics. Images shown for one patient and reporting system shown for a different patient, leading to the potential for misdiagnosis. | Siemens Medical Solutions USA, Inc |
| Devices | Reusable Clip Applier Manufactured by AtriCure, Inc., 6217 Centre Park Drive, West Chester, OH 45069. The Reusable Clip Applier (Applier) is intended to be used to deploy the Gillinov-Cosgrove LAA Clip (Clip). The Gillinov-Cosgrove LAA Clip (Clip) is an implantable device used for occlusion of the left atrial appendage. | Lot Number MFR-0424-1 | Class II | The firm was notified by a customer of a cracked spring in the handle of the RCD1 device. | Atricure Inc |
| Food | Creation Special Snack Mix; 25 lb. cardboard carton | Lot #s: 13037, 13114, 13309 and 13333. | Class II | Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs. | Dayton Nut Specialties Inc |
| Food | Bar Star Snack Mix; 25 lb. cardboard carton | Lot #s: 13013037, 13078, 13114, 13163, 13227, 13288 and 13333. | Class II | Due to the lack of the ingredient statement the firm failed to declare the following direct allergens: peanuts, tree nuts, soy, wheat, and yellow #5. The products also lack the declaration that they are packaged in a facility that handles milk and eggs. | Dayton Nut Specialties Inc |
| Devices | MEDITECH Microbiology; Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. Integrates requisition, specimen processing, and patient information with data in the healthcare information system (HCIS). | Client Server Releases 5.6, 5.65, 5.66, 5.67, 6.0, 6.05, 6.07, 6.1, 6.13 and 6.14. | Class II | Potential for erroneous result reporting. | Medical Information Technology, Inc. |
| Biologics | Source Plasma | 3520277021; 3520276367; 3520275784; 3520275235; 3520274652; 3520273706; 3520272384; 3520272017; 3520271116; 3520270771; 3520268608; 3520268234; 3520267426; 3520266968 | Class III | Blood products, collected from a donor who was previously deferred, were distributed. | Talecris Plasma Resources, Inc |
| Food | 4 oz. Heart - Shaped Box of Assorted Chocolates | 13344, 13345, 13361, 14010, 14014, 12365, and 13002. | Class I | Undeclared Allergen - peanut | Fannie May Confection Brands Inc |
| Devices | Medline Sterile Foley Catheter 14 fr 5 cc 12 pieces model number DNYD11914 Product Usage:Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes. | 540204R001 | Class II | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. | Convatec Inc. |
| Devices | Curion CuriStay Nelaton CH - 14 2-W Hydrogel Coated (Latex) 5- 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes. | 540204R001 | Class II | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. | Convatec Inc. |
| Devices | SLC 2-way standard Lubricious Coated 14ch/FR 5/10ml/cc Product Usage: Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes. | 540204R001 | Class II | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. | Convatec Inc. |
| Devices | JMS, Japan, 3 WAY, 20 FR 10 mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes. | 540204R001 | Class II | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. | Convatec Inc. |
| Devices | 'TORAY' Hydrocoat Foley Catheter 12 x10 4.00 mm Fr x mL Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes. | 540204R001 | Class II | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. | Convatec Inc. |
| Devices | SLC 3-way standard Lubricious Coated 20Ch/Fr 30 mL/cc Product Usage: Latex Lubricous Coated Foley Catheters The standard catheter essentially consists of a flexible lubricous coated latex tube which incorporates one major drainage lumen and one or two minor lumens constructed in the wall of the tube. One minor lumen is for inflating the retention balloon (available in 2-Way & 3-Way catheters). The second minor lumen (applicable for 3 Way catheters only) is used for bladder irrigation purposes. | 540204R001 | Class II | The lumen of the Medline Sterile Foley Catheter was found to be blocked by excess lubricious coating material. | Convatec Inc. |
| Devices | Oxoid Vancomycin 30 mcg, each cartridge contains 50 susceptibility discs, CT0058B. The firm name on the label is Oxoid Ltd., Basingstoke, Hampshire, England. Used in the semi-quantitative agar diffusion test method for in-vitro susceptibility testing. | Lot 1174497, exp. 2015/04 | Class II | Some of the discs may not be impregnated with the antibiotic. | Remel Inc |
| Devices | GE Healthcare Optima CT580/Discovery CT590RT scanners running software version 13BW16.3. The Discovery CT 590 RT and Optima CT 580 series of Computed Tomography systems are intended to produce cross-sectional images of the body by computer reconstruction of XRay transmission data taken at different angles and planes, including Axial, Cine, Helical (Volumetric), and Gated (Respiratory and Cardiac) acquisitions in patients of all ages. | Mfg Lot or Serial # PA2314840 PA2314841 PA2314842 PA2314843 PA2314844 PA2314845 A1RF3176G A1RF3638GR A2RF1052G B1RF4038GR B3G44377G B3G44511G B3G44515G B3RF4960G C1RF4686G C1RF4793G C1RF4802G C1RF4827GR D2RF2744G D2RF2778GR D2RF2795G D2RF2796G D2RF2797G D2RF2798G D2RF2799G D2RF2814G D2RF2815G D2RF2816G D2RF2817G D2RF2818G D2RF2819G D2RF2820G D2RF2821G D2RF2822G D2RF2823G D2RF2824G D2RF2825G D2RF2826G D2RF2827G D2RF2828G D2RF2829G D2RF2830G D2RF2831G D2RF2832G D2RF2833G D2RF2834G D2RF2835G D2RF2836G D2RF2837G D2RF2838G D2RF2839G D2RF2840G D2RF2841G D2RF2842G D2RF2843G D2RF2844G D2RF2845G D2RF2846G D2RF2847G D2RF2848G D2RF2850G D2RF2851G 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SJ812420937GA SJ812420944GA SJ812431060GA SJ812431061GA SJ812431062GA SJ812431063GA SJ812431064GA SJ812431065GA SJ812431066GA SJ812431068GA SJ812431069GA SJ812431070GA SJ812431071GA SJ812431072GA SJ812431074GA SJ812431075GA SJ812431076GA SJ812431077GA SJ812431078GA SJ812431079GA SJ812431081GA SJ812431082GA SJ812431084GA SJ812431086GA SJ812431087GA SJ812431088GA SJ812431089GA SJ812431091GA SJ812431092GA SJ812431094GA SJ812431095GA SJ812431096GA SJ812431098GA SJ812431099GA SJ812431105GA SJ812431106GA SJ812431107GA SJ812431109GA SJ812431110GA SJ812431111GA SJ812431112GA SJ812431113GA SJ812431114GA SJ812431115GA SJ812431116GA SJ812431117GA SJ812431118GA SJ812431119GA SJ812431120GA SJ812431121GA SJ812431122GA SJ812431123GA SJ812431124GA SJ812431125GA SJ812431126GA SJ812431127GA SJ812431128GA SJ812431129GA SJ812431130GA SJ812431131GA SJ812431135GA SJ812431136GA SJ812431137GA SJ812431138GA SJ812431139GA SJ812431140GA SJ812441141GA SJ812441143GA SJ812441144GA SJ812441145GA SJ812441146GA 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SJ813091379GA SJ813091380GA SJ813091391GA SJ813091392GA SJ813091393GA SJ813091394GA SJ813091395GA SJ813091396GA SJ813091397GA SJ813091398GA SJ813091399GA SJ813091400GA SJ813091405GA SJ813091406GA SJ813091407GA SJ813101411GA SJ813101412GA SJ813101423GA SJ813101424GA SJ813101427GA SJ813101428GA SJ813101429GA SJ813101430GA SJ813101431GA SJ813101432GA SJ813101433GA SJ813101435GA SJ813101439GA SJ813101440GA SJ813101441GA SJ813101442GA SJ813111445GA SJ813111449GA SJ813111452GA SJ813131454GA SJ813131455GA SJ813131456GA SJ813131457GA SJ813131458GA SJ813131459GA SJ813131460GA SJ813131461GA SJ813131462GA SJ813131463GA SJ813131465GA SJ813131466GA SJ813131467GA SJ813131468GA SJ813131469GA SJ813131470GA SJ813131472GA SJ813141484GA SJ813141485GA SJ813141486GA SJ813141487GA SJ813141488GA SJ813141489GA SJ813141490GA SJ813141491GA SJ813141492GA SJ813141493GA SJ813141494GA SJ813141495GA SJ813141496GA SJ813141498GA SJ813141499GA SJ813141500GA SJ813141501GA SJ813141502GA SJ813141503GA SJ813141505GA SJ813141506GA SJ813141507GA SJ813141508GA SJ813141509GA SJ813141510GA SJ813141512GA SJ813141513GA SJ813141514GA SJ813141517GA SJ813141518GA SJ813151519GA SJ813151520GA SJ813161539GA SJ813161540GA SJ813161541GA SJ813161542GA SJ813161543GA SJ813161544GA SJ813161545GA SJ813161546GA SJ813161547GA SJ813161548GA SJ813161549GA SJ813161550GA SJ813161552GA SJ813161553GA SJ813161555GA SJ813161556GA SJ813161558GA SJ813161559GA SJ813161563GA SJ813161564GA SJ813161565GA SJ813161566GA SJ813171569GA SJ813171570GA SJ813171571GA SJ813171576GA SJ813201587GA SJ813201591GA SJ813201592GA SJ813201594GA SJ813201597GA SJ813201599GA SJ813201600GA SJ813201602GA SJ813201604GA SJ813201605GA SJ813201606GA SJ813201607GA SJ813201610GA SJ813201611GA SJ813201612GA SJ813201613GA SJ813201614GA SJ813201615GA SJ813201617GA SJ813201620GA SJ813201623GA SJ813201625GA SJ813201626GA SJ813201627GA SJ813201628GA SJ813201641GA SJ813201642GA SJ813201643GA SJ813201644GA SJ813201646GA SJ813201647GA SJ813201648GA SJ813201649GA SJ813201650GA SJ813201651GA SJ813201653GA SJ813201654GA SJ813201655GA SJ813221666GA SJ813221667GA SJ813221668GA SJ813221669GA SJ813221670GA SJ813231671GA SJ813231672GA SJ813231673GA SJ813231676GA SJ813231677GA SJ813231678GA SJ813231679GA SJ813261726GA SJ813261727GA SJ813261728GA SJ813261729GA SJ813261730GA SJ813261731GA SJ813261732GA SJ813261733GA SJ813261734GA SJ813261735GA SJ813261736GA SJ813271754GA SJ813331846GA SJ813331847GA SJ813331848GA SJ813341851GA SJ813341852GA SJ813341853GA SJ813341854GA SJ813341855GA SJ813341856GA SJ813341857GA SJ813341858GA SJ813341859GA SJ813341861GA SJ813341862GA SJ813341863GA SJ813341864GA SJ813341865GA SJ813341866GA SJ813341867GA D1RF5130G D1RF5164G M1RF9796G PA2312626 SBH05440960GA SBH05450980GA SBM06261082GA SE410125060GA SE410175359GA SE410427727GA SE410427736GA SE411120829GA SE411120834GA SE411373361GA SE411373424GA SE411373430GA SE411373450GA PA1787323 PA1990529 PA1990530 PA1990531 PA1990532 PA1990533 PA1990534 PA1990535 PA1990536 PA1990537 PA1990902 PA2007151 R3T04490894GA R3T04490895GA R3T04490902GA R3T04490904GA R3T04490905GA R3T04490906GA R3T04490907GA R3T04490908GA R3T04490909GA R3T04490910GA R3T04490911GA R3T04490912GA R3T04490937GA R3T04490941GA R3T04490942GA R3T04490945GA R3T04490946GA R3T04490947GA R3T04490948GA R3T04490949GA R3T04490952GA R3T04490953GA R3T04490954GA R3T04490955GA R3T04490956GA SE410518952GA SE410034381GA A3G44075G SE410296397GA SE410306446GA SE410306448GA SE410084705GA SE410084821GA SE411171508GA SE411171514GA A43T2648G A43T2827G A43T2828G A43T2829G G2RF3761G G2RF3769G J2G42141G J2G42142G J2G42144G J2G42146G J2G42149G J2G42150G L33T1515G L33T1516G L33T1519G L33T1520G L33T1521G L33T1522G L33T1523G L33T1524G L33T1525G L33T1526G L33T1527G L33T1529G L33T1530G L33T1531G L33T1532G L33T1533G L33T1535G L33T1536G L33T1537G PA1786866 PA1787409 PA1787410 PA1787411 PA1787412 PA1787413 PA1787414 PA1787415 PA1787416 PA1787417 PA1787418 PA1787419 PA1787420 PA1787421 PA1787422 PA1787423 PA1787424 PA1787425 PA1787426 PA1787427 PA1787428 PA1787429 PA1787430 PA1787431 PA1787432 PA1787433 PA1853043 PA1853044 PA1853045 PA1853046 PA1853047 PA1853048 PA1853049 PA1853050 PA1853051 PA1853052 PA1853053 PA1853054 PA1853055 PA1853056 PA1853057 PA1853058 PA1853059 PA1853060 PA1853061 PA1853062 PA1853063 PA1853064 PA1853065 PA1853066 PA1853067 PA1853068 PA1853069 PA1853070 PA1853071 PA1853072 PA2138233 PA2138290 PA2139685 PA2139686 PA2139687 PA2139688 PA2139689 PA2139690 PA2139691 PA2139692 PA2139693 PA2139694 R3T04490969GA R3T04490970GA SE409452977GA SE409473201GA SE409473202GA SE409473203GA SE409473204GA SE409473205GA SE409473206GA SE409473207GA SE409473208GA SE409473215GA SE409473216GA SE409473217GA SE409473221GA SE409473237GA SE409473238GA SE409473250GA SE409473257GA SE409473258GA SE409483260GA SE409483261GA SE409483262GA SE409483263GA SE409483265GA SE409493348GA SE409493356GA SE409493361GA SE409493375GA SE409493379GA SE409493382GA SE409493385GA SE409493394GA SE409493401GA SE409493405GA SE409493406GA SE409493411GA SE409503428GA SE409503443GA SE409503446GA SE409503447GA SE409503449GA SE409503456GA SE409503458GA SE409503460GA SE409503482GA SE409503484GA SE410034386GA SE410064659GA SE410064661GA SE410064662GA SE410064663GA SE410064664GA SE410064665GA SE410064666GA SE410064667GA SE410064668GA SE410064669GA SE410074670GA SE410074671GA SE410074672GA SE410074673GA SE410074674GA SE410074675GA SE410074682GA SE410074683GA SE410074686GA SE410084749GA SE410155177GA SE410468097GA SE410468099GA SE410468105GA SE410488599GA SE410488602GA SE411191642GA SE411302542GA SE411302544GA SE411302550GA SE411302564GA SE411302573GA SE411312693GA SE411322865GA SE411322872GA SE411332985GA SE411332992GA SE411332994GA SE411332999GA SE411343032GA SE411373350GA SE411373354GA SE411373363GA SE411373365GA SE411373366GA SE411373377GA SE411373379GA SE411373380GA SE411373384GA SE411373385GA SE411373419GA SE411373423GA SE411373428GA SE411373438GA SE411383486GA SE411383497GA SE411383502GA SE411383534GA SE411383535GA SE411383537GA SE411383538GA SE411383544GA SE411383545GA SE411383550GA SE411383557GA SE411383565GA SE411393687GA SE411393693GA SE411393695GA SE411393704GA SE411393705GA SE411393709GA D1RF4986G SE411141030GA SE409432600GA SE409442784GA SE409442790GA SE409452881GA SE409452883GA SE409452884GA SE409452904GA SE409452910GA SE409452912GA SE409493387GA SE409503502GA SE409503518GA SE409503526GA SE409503528GA SE409503529GA SE409503530GA SE409503532GA SE409503533GA SE409503534GA SE409503536GA SE409503537GA SE409503538GA SE409503541GA SE409503542GA SE409503543GA SE409503551GA SE409503552GA SE409503556GA SE409503572GA SE409503574GA SE409503578GA SE409503579GA SE409503588GA SE409503590GA SE409503591GA SE409503594GA SE409503595GA SE409503596GA SE409503597GA SE409503598GA SE409503599GA SE409503600GA SE409503602GA SE409503603GA SE409503606GA SE409503610GA SE409503613GA SE409503615GA SE409503621GA SE409503622GA SE409503629GA SE409503630GA SE409503631GA SE409503632GA SE409513647GA SE409513648GA SE409513649GA SE409513652GA SE409513660GA SE409513662GA SE409513663GA SE409513664GA SE409513666GA SE409513668GA SE409513669GA SE409513672GA SE409513673GA SE409513675GA SE409513676GA SE409513677GA SE409513723GA SE409523904GA SE409523909GA SE409523913GA SE409523924GA SE409523925GA SE409523926GA SE409523927GA SE409523928GA SE409523929GA SE409523930GA SE409523931GA SE409523936GA SE409523937GA SE409523940GA SE409523943GA SE409523944GA SE409523945GA SE409523946GA SE409523954GA SE409523956GA SE409523958GA SE409523977GA SE409523979GA SE409523980GA SE409523985GA SE409523986GA SE409523991GA SE409523993GA SE409523994GA SE409523995GA SE409534041GA SE409534048GA SE409534055GA SE409534065GA SE409534084GA SE410024201GA SE410024209GA SE410024214GA SE410024241GA SE410024246GA SE410024247GA SE410024248GA SE410024249GA SE410024250GA SE410024251GA SE410024252GA SE410024253GA SE410024254GA SE410024255GA SE410024256GA SE410024257GA SE410024258GA SE410024259GA SE410024260GA SE410024261GA 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J3RF5385G L2G42991G L2G42992G L33T1207G M2RF4710G PA1786861 PA1786862 PA1786863 PA1786864 PA1786865 PA1851812 PA1851813 PA1852107 PA1852108 PA1852109 PA1852110 PA1852111 PA1852112 PA1852113 PA1852114 PA1852115 PA1852116 PA1852117 PA1852118 PA1852119 PA1852120 PA1852121 PA1852122 PA1852123 PA1852124 PA1852125 PA1852126 PA1852127 PA1852128 PA1852129 PA1852130 PA1852131 PA1852132 PA1852133 PA1852134 PA1852135 PA1852136 PA1852137 R3T04501056GA SE410255956GA A2RF1130G C1RF4826G H2G41514G SE410115035GA SE410125053GA SE410125057GA SE410125059GA SE410125065GA SE410125066GA SE410125067GA SE410125068GA SE410125069GA SE410125070GA SE410125071GA SE410125072GA SE410266170GA SE410266171GA SE410266172GA SE410266173GA SE410276213GA SE410276216GA SE411120801GA SE411120802GA SE411120803GA SE411120805GA SE411120806GA SE411120808GA SE411120809GA SE411120810GA SE411120812GA SE411120815GA SE411130956GA SE411130958GA SE411141081GA SE411141083GA SE411141084GA SE411141085GA SE411141086GA SE411141087GA 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Healthcare has recently become aware of a potential safety issue due to a software issue associated with the Head Scan Protocols used on your Optima CT580 or Discovery CT590RT scanner. A potential hazardous situation may occur during a CT head scan causing a novel and rare artifact that may hide pathology. When using the head and large head SFOV, which applies the Iterative Bone Option (IBO), the image clarity between the cranial -brain interface, may not be clinically acceptable. The artifact degrades image quality at the boundary between the cranium and brain surface, but does not affect the bone image quality. No injuries have been reported to date. | GE Healthcare, LLC |
| Biologics | Red Blood Cells | 2262099; 2365718; 2233002 | Class II | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. | OneBlood, Inc. |
| Biologics | Fresh Frozen Plasma | 2233002 | Class II | Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. | OneBlood, Inc. |
| Devices | Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. | Catalog Number 4934 | Class II | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | Terumo Cardiovascular Systems Corporation |
| Devices | Sarns Malleable Dual-stage Venous Return Cannulae, 28/38 Fr with 1/2" connector, 14.5" (37 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. | Catalog Number 4934X | Class II | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | Terumo Cardiovascular Systems Corporation |
| Devices | Sarns Malleable Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. | Catalog Number 4935 | Class II | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | Terumo Cardiovascular Systems Corporation |
| Devices | Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. | Catalog Number 4936 | Class II | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | Terumo Cardiovascular Systems Corporation |
| Devices | Sarns Malleable Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" connector, 15" (38 cm) long, with X Coating The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. | Catalog Number 4936X | Class II | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | Terumo Cardiovascular Systems Corporation |
| Devices | Sarns Dual-stage Venous Return Cannulae, 32/40 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. | Catalog Number 16472 | Class II | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | Terumo Cardiovascular Systems Corporation |
| Devices | Sarns Dual-stage Venous Return Cannulae, 34/46 Fr with 1/2" flare The Sarns Malleable Dual-stage Venous Return Catheters and Sarns Dual-stage Venous Return Cannula are indicated for single-tube venous drainage from the right atrium and vena cava during cardiopulmonary bypass surgery. These devices are indicated for up to 6 hours of use. | Catalog Number 16473 | Class II | During in-process inspection, Terumo Cardiovascular Systems (Terumo CVS) identified exposed basket wire on certain product lots of Sarns Malleable Dual-stage Venous Return Cannulae and Sarns Dual-stage Venous Return Cannulae. | Terumo Cardiovascular Systems Corporation |
| Devices | Philips HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs). Product Usage: The models M5066A, M5067A, and M5068A are designed for use on a person in sudden cardiac arrest who is: -Unresponsive when shaken -Not breathing normally If in doubt, apply the pads. A training class in CPR/AED use is recommended for anyone who may use the HS1. If the person is an infant or child younger than eight years old or weighs less than 55 lbs (25 kg), use the special infant/child pads. If the child appears older/larger, use the adult pads. Do not delay treatment to determine the child s exact age or weight. If in doubt, use the adult pads. Models M5066A (for HS1 Onsite), M5067A (OnSite) , and M5068A (for HS1 Home). | SERIAL NUMBERS OF UNITS DISTRIBUTED IN THE USA: A13G-00001, A13G-00002, A13G-00003, A13G-00004, A13G-00005, A13G-00006, A13G-00007, A13G-00008, A13G-00009, A13G-00010, A13G-00011, A13G-00012, A13G-00013, A13G-00014, A13G-00015, A13G-00016, A13G-00017, A13G-00018, A13G-00019, A13G-00020, A13G-00021, A13G-00022, A13G-00023, A13G-00024, A13G-00025, A13G-00026, A13G-00027, A13G-00028, A13G-00029, A13G-00030, A13G-00031, A13G-00032, A13G-00033, A13G-00034, A13G-00035, A13G-00036, A13G-00037, A13G-00038, A13G-00039, A13G-00040, A13G-00041, A13G-00042, A13G-00043, A13G-00044, A13G-00045, A13G-00046, A13G-00047, A13G-00048, A13G-00049, A13G-00050, A13G-00051, A13G-00052, A13G-00053, A13G-00054, A13G-00055, A13G-00056, A13G-00057, A13G-00058, A13G-00059, A13G-00060, A13G-00061, A13G-00062, A13G-00063, A13G-00064, A13G-00065, A13G-00067, A13G-00068, A13G-00069, A13G-00070, A13G-00071, A13G-00072, A13G-00073, A13G-00074, A13G-00075, A13G-00076, A13G-00077, A13G-00078, A13G-00079, A13G-00080, A13G-00081, A13G-00082, A13G-00083, A13G-00084, A13G-00085, A13G-00086, A13G-00087, A13G-00088, A13G-00089, A13G-00090, A13G-00091, A13G-00092, A13G-00093, A13G-00095, A13G-00096, A13G-00097, A13G-00098, A13G-00099, A13G-00100, A13G-00101, A13G-00102, A13G-00103, A13G-00104, A13G-00105, A13G-00106, A13G-00107, A13G-00108, A13G-00109, A13G-00110, A13G-00111, A13G-00112, A13G-00114, A13G-00115, A13G-00116, A13G-00117, A13G-00118, A13G-00119, A13G-00120, A13G-00122, A13G-00123, A13G-00124, A13G-00125, A13G-00126, A13G-00127, A13G-00128, A13G-00129, A13G-00130, A13G-00131, A13G-00132, A13G-00133, A13G-00134, A13G-00135, A13G-00136, A13G-00137, A13G-00138, A13G-00139, A13G-00140, A13G-00141, A13G-00142, A13G-00143, A13G-00144, A13G-00145, A13G-00146, A13G-00147, A13G-00148, A13G-00149, A13G-00150, A13G-00151, A13G-00152, A13G-00153, A13G-00154, A13G-00155, A13G-00156, A13G-00157, A13G-00158, A13G-00159, A13G-00160, A13G-00161, A13G-00162, A13G-00163, A13G-00164, A13G-00165, A13G-00166, A13G-00167, A13G-00168, A13G-00169, A13G-00170, A13G-00171, A13G-00172, A13G-00173, A13G-00174, A13G-00175, A13G-00176, A13G-00177, A13G-00178, A13G-00179, A13G-00180, A13G-00181, A13G-00182, A13G-00183, A13G-00184, A13G-00185, A13G-00186, A13G-00187, A13G-00188, A13G-00189, A13G-00190, A13G-00192, A13G-00193, A13G-00194, A13G-00195, A13G-00196, A13G-00197, A13G-00198, A13G-00199, A13G-00201, A13G-00202, A13G-00204, A13G-00215, A13G-00222, A13G-00223, A13G-00258, A13G-00259, A13G-00260, A13G-00261, A13G-00262, A13G-00263, A13G-00264, A13G-00265, A13G-00277, A13G-00288, A13G-00289, A13G-00294, A13G-00325, A13G-00336, A13G-00337, A13G-00338, A13G-00339, A13G-00340, A13G-00341, A13G-00342, A13G-00343, A13G-00344, A13G-00345, A13G-00355, A13G-00356, A13G-00359, A13G-00375, A13G-00376, A13G-00377, A13G-00378, A13G-00379, A13G-00380, A13G-00381, A13G-00403, A13G-00404, A13G-00406, A13G-00407, A13G-00408, A13G-00409, A13G-00410, A13G-00415, A13G-00417, A13G-00418, A13G-00419, A13G-00420, A13G-00421, A13G-00423, A13G-00435, A13G-00444, A13G-00448, A13G-00449, A13G-00450, A13G-00451, A13G-00452, A13G-00453, A13G-00454, A13G-00455, A13G-00456, A13G-00457, A13G-00458, A13G-00459, A13G-00460, A13G-00461, A13G-00462, A13G-00463, A13G-00464, A13G-00465, A13G-00466, A13G-00468, A13G-00469, A13G-00470, A13G-00477, A13G-00478, A13G-00485, A13G-00490, A13G-00493, A13G-00495, A13G-00496, A13G-00497, A13G-00498, A13G-00499, A13G-00500, A13G-00501, A13G-00502, A13G-00503, A13G-00509, A13G-00511, A13G-00513, A13G-00514, A13G-00552, A13G-00554, A13G-00555, A13G-00559, A13G-00561, A13G-00562, A13G-00563, A13G-00565, A13G-00569, A13G-00572, A13G-00573, A13G-00577, A13G-00588, A13G-00610, A13G-00611, A13G-00612, A13G-00614, A13G-00615, A13G-00620, A13G-00621, A13G-00622, A13G-00623, A13G-00624, A13G-00626, A13G-00627, A13G-00633, A13G-00635, A13G-00637, A13G-00639, A13G-00643, A13G-00653, A13G-00659, A13G-00660, A13G-00661, A13G-00662, A13G-00663, A13G-00664, A13G-00674, A13G-00676, A13G-00677, A13G-00678, A13G-00679, A13G-00680, A13G-00681, A13G-00682, A13G-00685, A13G-00686, A13G-00687, A13G-00688, A13G-00689, A13G-00690, A13G-00691, A13G-00692, A13G-00693, A13G-00696, A13G-00697, A13G-00698, A13G-00699, A13G-00705, A13G-00706, A13G-00710, A13G-00713, A13G-00716, A13G-00717, A13G-00719, A13G-00723, A13G-00724, A13G-00726, A13G-00730, A13G-00732, A13G-00733, A13G-00734, A13G-00735, A13G-00737, A13G-00746, A13G-00749, A13G-00750, A13G-00751, A13G-00753, A13G-00754, A13G-00756, A13G-00757, A13G-00770, A13G-00772, A13G-00779, A13G-00782, A13G-00783, A13G-00784, A13G-00785, A13G-00786, A13G-00787, A13G-00788, A13G-00793, A13G-00796, A13G-00797, A13G-00798, A13G-00799, A13G-00804, A13G-00805, A13G-00806, A13G-00811, A13G-00814, A13G-00817, A13G-00818, A13G-00819, A13G-00824, A13G-00826, A13G-00827, A13G-00828, A13G-00829, A13G-00833, A13G-00834, A13G-00835, A13G-00836, A13G-00837, A13G-00838, A13G-00840, A13G-00842, A13G-00843, A13G-00844, A13G-00846, A13G-00847, A13G-00851, A13G-00852, A13G-00853, A13G-00854, A13G-00855, A13G-00856, A13G-00859, A13G-00860, A13G-00861, A13G-00862, A13G-00863, A13G-00865, A13G-00870, A13G-00874, A13G-00875, A13G-00877, A13G-00878, A13G-00880, A13G-00881, A13G-00883, A13G-00884, A13G-00885, A13G-00886, A13G-00887, A13G-00889, A13G-00891, A13G-00892, A13G-00894, A13G-00896, A13G-00897, A13G-00898, A13G-00899, A13G-00900, A13G-00902, A13G-00903, A13G-00904, A13G-00905, A13G-00906, A13G-00907, A13G-00908, A13G-00909, A13G-00910, A13G-00911, A13G-00912, A13G-00913, A13G-00914, A13G-00915, A13G-00916, A13G-00917, A13G-00918, A13G-00919, A13G-00920, A13G-00921, A13G-00922, A13G-00923, A13G-00924, A13G-00925, A13G-00927, A13G-00928, A13G-00929, A13G-00930, A13G-00931, A13G-00932, A13G-00933, A13G-00934, A13G-00935, A13G-00936, A13G-00937, A13G-00938, A13G-00939, A13G-00940, A13G-00943, A13G-00944, A13G-00945, A13G-00946, A13G-00947, A13G-00948, A13G-00949, A13G-00950, A13G-00951, A13G-00952, A13G-00953, A13G-00954, A13G-00955, A13G-00956, A13G-00957, A13G-00958, A13G-00959, A13G-00960, A13G-00961, A13G-00962, A13G-00963, A13G-00964, A13G-00965, A13G-00967, A13G-00968, A13G-00969, A13G-00970, A13G-00971, A13G-00972, A13G-00973, A13G-00974, A13G-00975, A13G-00976, A13G-00977, A13G-00978, A13G-00979, A13G-00980, A13G-00981, A13G-00982, A13G-00983, A13G-00984, A13G-00985, A13G-00986, A13G-00987, A13G-00988, A13G-00989, A13G-00990, A13G-00991, A13G-00992, A13G-00993, A13G-00994, A13G-00995, A13G-00996, A13G-00997, A13G-00998, A13G-00999, A13G-01000, A13G-01001, A13G-01002, A13G-01003, A13G-01004, A13G-01005, A13G-01006, A13G-01007, A13G-01008, A13G-01009, A13G-01010, A13G-01011, A13G-01013, A13G-01014, A13G-01015, A13G-01016, A13G-01017, A13G-01019, A13G-01020, A13G-01021, A13G-01022, A13G-01023, A13G-01025, A13G-01028, A13G-01029, A13G-01031, A13G-01032, A13G-01033, A13G-01035, A13G-01036, A13G-01037, A13G-01038, A13G-01039, A13G-01040, A13G-01041, A13G-01042, A13G-01043, A13G-01044, A13G-01045, A13G-01046, A13G-01047, A13G-01048, A13G-01049, A13G-01050, A13G-01051, A13G-01052, A13G-01053, A13G-01054, A13G-01055, A13G-01056, A13G-01057, A13G-01058, A13G-01059, A13G-01060, A13G-01061, A13G-01062, A13G-01063, A13G-01064, A13G-01065, A13G-01066, A13G-01067, A13G-01068, A13G-01069, A13G-01070, A13G-01072, A13G-01074, A13G-01077, A13G-01081, A13G-01086, A13G-01088, A13G-01090, A13G-01093, A13G-01107, A13G-01108, A13G-01109, A13G-01110, A13G-01111, A13G-01113, A13G-01131, A13G-01134, A13G-01136, A13G-01137, A13G-01138, A13G-01139, A13G-01140, A13G-01141, A13G-01142, A13G-01143, A13G-01144, A13G-01145, A13G-01146, A13G-01147, A13G-01148, A13G-01149, A13G-01150, A13G-01151, A13G-01152, A13G-01153, A13G-01154, A13G-01155, A13G-01156, A13G-01157, A13G-01158, A13G-01159, A13G-01160, A13G-01161, A13G-01162, A13G-01163, A13G-01164, A13G-01165, A13G-01167, A13G-01168, A13G-01169, A13G-01170, A13G-01171, A13G-01172, A13G-01173, A13G-01174, A13G-01175, A13G-01176, A13G-01177, A13G-01178, A13G-01179, A13G-01180, A13G-01181, A13G-01182, A13G-01184, A13G-01185, A13G-01186, A13G-01187, A13G-01188, A13G-01189, A13G-01190, A13G-01191, A13G-01192, A13G-01193, A13G-01194, A13G-01195, A13G-01196, A13G-01197, A13G-01198, A13G-01199, A13G-01201, A13G-01202, A13G-01203, A13G-01204, A13G-01205, A13G-01207, A13G-01208, A13G-01209, A13G-01210, A13G-01211, A13G-01212, A13G-01213, A13G-01214, A13G-01215, A13G-01216, A13G-01217, A13G-01218, A13G-01219, A13G-01220, A13G-01221, A13G-01222, A13G-01223, A13G-01224, A13G-01225, A13G-01226, A13G-01227, A13G-01228, A13G-01229, A13G-01230, A13G-01231, A13G-01232, A13G-01233, A13G-01234, A13G-01235, A13G-01236, A13G-01237, A13G-01238, A13G-01239, A13G-01240, A13G-01241, A13G-01242, A13G-01243, A13G-01244, A13G-01245, A13G-01246, A13G-01247, A13G-01248, A13G-01249, A13G-01250, A13G-01251, A13G-01252, A13G-01253, A13G-01254, A13G-01255, A13G-01256, A13G-01257, A13G-01258, A13G-01259, A13G-01260, A13G-01261, A13G-01262, A13G-01263, A13G-01264, A13G-01265, A13G-01266, A13G-01267, A13G-01268, A13G-01269, A13G-01270, A13G-01271, A13G-01272, A13G-01273, A13G-01274, A13G-01275, A13G-01276, A13G-01277, A13G-01278, A13G-01279, A13G-01280, A13G-01281, A13G-01282, A13G-01284, A13G-01285, A13G-01286, A13G-01287, A13G-01288, A13G-01289, A13G-01290, A13G-01291, A13G-01292, A13G-01293, A13G-01294, A13G-01296, A13G-01297, A13G-01298, A13G-01299, A13G-01300, A13G-01301, A13G-01302, A13G-01303, A13G-01304, A13G-01305, A13G-01306, A13G-01307, A13G-01308, A13G-01309, A13G-01310, A13G-01311, A13G-01312, A13G-01313, A13G-01314, A13G-01315, A13G-01316, A13G-01317, A13G-01318, A13G-01319, A13G-01320, A13G-01321, A13G-01322, A13G-01323, A13G-01324, A13G-01325, A13G-01326, A13G-01327, A13G-01328, A13G-01329, A13G-01330, A13G-01331, A13G-01332, A13G-01333, A13G-01334, A13G-01335, A13G-01336, A13G-01337, A13G-01338, A13G-01339, A13G-01340, A13G-01341, A13G-01342, 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A13G-03765, A13G-03766, A13G-03767, A13G-03768, A13G-03769, A13G-03770, A13G-03771, A13G-03777, A13G-03778, A13G-03779, A13G-03780, A13G-03781, A13G-03782, A13G-03783, A13G-03784, A13G-03785, A13G-03786, A13G-03787, A13G-03788, A13G-03789, A13G-03790, A13G-03791, A13G-03793, A13G-03794, A13G-03795, A13G-03796, A13G-03797, A13G-03798, A13G-03799, A13G-03800, A13G-03801, A13G-03802, A13G-03804, A13G-03805, A13G-03806, A13G-03807, A13G-03808, A13G-03809, A13G-03810, A13G-03811, A13G-03812, A13G-03813, A13G-03814, A13G-03815, A13G-03816, A13G-03817, A13G-03818, A13G-03819, A13G-03820, A13G-03821, A13G-03822, A13G-03823, A13G-03824, A13G-03825, A13G-03826, A13G-03827, A13G-03828, A13G-03829, A13G-03830, A13G-03831, A13G-03832, A13G-03833, A13G-03834, A13G-03835, A13G-03836, A13G-03837, A13G-03838, A13G-03839, A13G-03840, A13G-03841, A13G-03842, A13G-03843, A13G-03844, A13G-03845, A13G-03850, A13G-03852, A13G-03853, A13G-03854, A13G-03855, A13G-03856, A13G-03857, A13G-03858, A13G-03859, A13G-03860, A13G-03861, A13G-03862, A13G-03863, A13G-03864, A13G-03871, A13G-03872, A13G-03874, A13G-03877, A13G-03878, A13G-03879, A13G-03880, A13G-03881, A13G-03882, A13G-03885, A13G-03886, A13G-03887, A13G-03888, A13G-03889, A13G-03890, A13G-03891, A13G-03909, A13G-03911, A13G-03914, A13G-03915, A13G-03916, A13G-03917, A13G-03918, A13G-03923, A13G-03924, A13G-03926, A13G-03927, A13G-03928, A13G-03929, A13G-03931, A13G-03937, A13G-03941, A13G-03943, A13G-03944, A13G-03949, A13G-03953, A13G-03954, A13G-03962, A13G-04029, A13G-04034, A13G-04036, A13G-04049, A13G-04050, A13G-04051, A13G-04056, A13G-04057, A13G-04059, A13G-04062, A13G-04066, A13G-04088, A13G-04089, A13G-04090, A13G-04092, A13G-04115, A13G-04116, A13G-04117, A13G-04118, A13G-04119, A13G-04123, A13G-04124, A13G-04207, A13G-04208, A13G-04209, A13G-04210, A13G-04211, A13G-04212, A13G-04213, A13G-04214, A13G-04220, A13G-04221, A13G-04222, A13G-04223, A13G-04224, A13G-04225, A13G-04227, A13G-04228, A13G-04230, A13G-04232, A13G-04233, A13G-04235, A13G-04238, A13G-04242, A13G-04243, A13G-04244, A13G-04245, A13G-04246, A13G-04247, A13G-04248, A13G-04249, A13G-04250, A13G-04251, A13G-04252, A13G-04256, A13G-04259, A13G-04260, A13G-04261, A13G-04262, A13G-04263, A13G-04264, A13G-04265, A13G-04266, A13G-04267, A13G-04268, A13G-04269, A13G-04270, A13G-04271, A13G-04273, A13G-04282, A13G-04297, A13G-04298, A13G-04299, A13G-04300, A13G-04301, A13G-04302, A13G-04303, A13G-04304, A13G-04305, A13G-04306, A13G-04307, A13G-04308, A13G-04309, A13G-04310, A13G-04311, A13G-04312, A13G-04313, A13G-04314, A13G-04315, A13G-04316, A13G-04317, A13G-04318, A13G-04319, A13G-04320, A13G-04321, A13G-04323, A13G-04324, A13G-04325, A13G-04326, A13G-04332, A13G-04333, A13G-04335, A13G-04336, A13G-04337, A13G-04338, A13G-04339, A13G-04340, A13G-04341, A13G-04342, A13G-04344, A13G-04345, A13G-04346, A13G-04347, A13G-04348, A13G-04349, A13G-04362, A13G-04363, A13G-04364, A13G-04365, A13G-04366, A13G-04369, A13G-04370, A13G-04371, A13G-04372, A13G-04374, A13G-04375, A13G-04376, A13G-04377, A13G-04378, A13G-04379, A13G-04380, A13G-04381, A13G-04382, A13G-04383, A13G-04384, A13G-04385, A13G-04386, A13G-04387, A13G-04388, A13G-04389, A13G-04390, A13G-04391, A13G-04392, A13G-04393, A13G-04394, A13G-04395, A13G-04396, A13G-04397, A13G-04398, A13G-04399, A13G-04401, A13G-04402, A13G-04403, A13G-04404, A13G-04405, A13G-04406, A13G-04407, A13G-04408, A13G-04409, A13G-04410, A13G-04411, A13G-04412, A13G-04414, A13G-04415, A13G-04416, A13G-04417, A13G-04418, A13G-04419, A13G-04421, A13G-04422, A13G-04423, A13G-04424, A13G-04425, A13G-04426, A13G-04427, A13G-04428, A13G-04429, A13G-04430, A13G-04431, A13G-04432, A13G-04433, A13G-04434, A13G-04435, A13G-04436, A13G-04437, A13G-04438, A13G-04439, A13G-04440, A13G-04441, A13G-04442, A13G-04443, A13G-04444, A13G-04445, A13G-04446, A13G-04447, A13G-04448, A13G-04449, A13G-04450, A13G-04451, A13G-04452, A13G-04453, A13G-04454, A13G-04455, A13G-04456, A13G-04457, A13G-04458, A13G-04460, A13G-04462, A13G-04463, A13G-04464, A13G-04465, A13G-04466, A13G-04467, A13G-04468, A13G-04469, A13G-04473, A13G-04474, A13G-04475, A13G-04476, A13G-04477, A13G-04483, A13G-04484, A13G-04485, A13G-04486, A13G-04487, A13G-04488, A13G-04489, A13G-04490, A13G-04491, A13G-04493, A13G-04495, A13G-04496, A13G-04497, A13G-04498, A13G-04501, A13G-04502, A13G-04503, A13G-04504, A13G-04505, A13G-04506, A13G-04507, A13G-04508, A13G-04510, A13G-04511, A13G-04512, A13G-04513, A13G-04514, A13G-04515, A13G-04516, A13G-04517, A13G-04518, A13G-04519, A13G-04520, A13G-04521, A13G-04522, A13G-04525, A13G-04526, A13G-04527, A13G-04528, A13G-04529, A13G-04530, A13G-04531, A13G-04532, A13G-04533, A13G-04534, A13G-04535, A13G-04536, A13G-04537, A13G-04538, A13G-04539, A13G-04540, A13G-04541, A13G-04542, A13G-04543, A13G-04544, A13G-04545, A13G-04546, A13G-04547, A13G-04548, A13G-04549, A13G-04551, A13G-04552, A13G-04553, A13G-04554, A13G-04555, A13G-04556, A13G-04561, A13G-04562, A13G-04563, A13G-04565, A13G-04567, A13G-04568, A13G-04569, A13G-04570, A13G-04571, A13G-04572, A13G-04573, A13G-04574, A13G-04575, A13G-04593, A13G-04594, A13G-04595, A13G-04601, A13G-04602, A13G-04603, A13G-04604, A13G-04605, A13G-04606, A13G-04607, A13G-04609, A13G-04610, A13G-05031, A13G-05034, A13G-05035, A13G-05055, A13G-05057, A13G-05059, A13G-05067, A13G-05068, A13G-05069, A13G-05070, A13G-05071, A13G-05073, A13G-05081, A13G-05082, A13G-05083, A13G-05084, A13G-05085, A13G-05090, A13G-05151, A13G-05152, A13G-05153, A13G-05154, A13G-05155, A13G-05156, A13G-05157, A13G-05158, A13G-05160, A13G-05161, A13G-05162, A13G-05163, A13G-05164, A13G-05165, A13G-05166, A13G-05167, A13G-05168, A13G-05169, A13G-05170, A13G-05171, A13G-05172, A13G-05173, A13G-05174, A13G-05180, A13G-05197, A13G-05198, A13G-05199, A13G-05201, A13G-05202, A13G-05203, A13G-05205, A13G-05212, A13G-05214, A13G-05215, A13G-05218, A13G-05221, A13G-05224, A13G-05225, A13G-05227, A13G-05228, A13G-05229, A13G-05230, A13G-05234, A13G-05235, A13G-05236, A13G-05237, A13G-05238, A13G-05239, A13G-05242, A13G-05246, A13G-05247, A13G-05250, A13G-05252, A13G-05253, A13G-05256, A13G-05257, A13G-05261, A13G-05262, A13G-05269, A13G-05270, A13G-05286, A13G-05288, A13G-05290, A13G-05291, A13G-05294, A13G-05296, A13G-05301, A13G-05308, A13G-05312, A13G-05313, A13G-05314, A13G-05316, A13G-05319, A13G-05321, A13G-05322, A13G-05326, A13G-05328, A13G-05329, A13G-05330, A13G-05331, A13G-05334, A13G-05336, A13G-05342, A13G-05343, A13G-05344, A13G-05346, A13G-05347, A13G-05349, A13G-05364, A13G-05365, A13G-05366, A13G-05367, A13G-05372, A13G-05374, A13G-05375, A13G-05386, A13G-05387, A13G-05388, A13G-05389, A13G-05390, A13G-05392, A13G-05393, A13G-05394, A13G-05395, A13G-05396, A13G-05397, A13G-05398, A13G-05406, A13G-05408, A13G-05409, A13G-05410, A13G-05411, A13G-05412, A13G-05420, A13G-05423, A13G-05427, A13G-05428, A13G-05429, A13G-05450, A13G-05451, A13G-05452, A13G-05454, A13G-05455, A13G-05460, A13G-05476, A13G-05489, A13G-05491, A13G-05495, A13G-05496, A13G-05497, A13G-05498, A13G-05499, A13G-05500, A13G-05501, A13G-05502, A13G-05503, A13G-05504, A13G-05507, A13G-05520, A13G-05521, A13G-05522, A13G-05524, A13G-05525, A13G-05526, A13G-05527, A13G-05528, A13G-05545, A13G-05550, A13G-05551, A13G-05552, A13G-05555, A13G-05556, A13G-05557, A13G-05558, A13G-05559, A13G-05560, A13G-05561, A13G-05562, A13G-05563, A13G-05564, A13G-05565, A13G-05566, A13G-05567, A13G-05568, A13G-05569, A13G-05570, A13G-05571, A13G-05572, A13G-05573, A13G-05574, A13G-05575, A13G-05576, A13G-05577, A13G-05578, A13G-05589, A13G-05622, A13G-05623, A13G-05624, A13G-05625, A13G-05626, A13G-05627, A13G-05628, A13G-05629, A13G-05630, A13G-05631, A13G-05634, A13G-05635, A13G-05636, A13G-05637, A13G-05638, A13G-05639, A13G-05640, A13G-05642, A13G-05643, A13G-05644, A13G-05645, A13G-05646, A13G-05647, A13G-05648, A13G-05649, A13G-05732, A13G-05733, A13G-05734, A13G-05735, A13G-05736, A13G-05738, A13G-05739, A13G-05740, A13G-05741, A13G-05742, A13G-06169, A13G-06170, A13G-06171, A13G-06174, A13G-06175, A13G-06176, A13G-06198, A13G-06213, A13G-06214, A13G-06250, A13G-06251, A13G-06252, A13G-06253, A13G-06254, A13G-06255, A13G-06256, A13G-06257, A13G-06258, A13G-06311, A13G-06312, A13G-06313, A13G-06314, A13G-06315, A13G-06316, A13G-06317, A13G-06439, A13G-06440, A13G-06441, A13G-06442, A13G-06443, A13G-06446, A13G-06447, A13G-06448, A13G-06449, A13G-06450, A13G-06451, A13G-06452, A13G-06453, A13G-06455, A13G-06456, A13G-06458, A13G-06461, A13G-06462, A13G-06531, A13G-06534, A13G-06535, A13G-06536, A13G-06537, A13G-06538, A13G-06540, A13G-06541, A13G-06542, A13G-06546, A13G-06547, A13G-06548, A13G-06549, A13G-06551, A13G-06552, A13G-06553, A13G-06555, A13G-06557, A13G-06558, A13G-06559, A13G-06560, A13G-06561, A13G-06562, A13G-06564, A13G-06566, A13G-06567, A13G-06568, A13G-06569, A13G-06570, A13G-06571, A13G-06572, A13G-06573, A13G-06574, A13G-06575, A13G-06576. SERIAL NUMBERS OF UNITS DISTRIBUTED OUTSIDE THE USA: A13G-00066, A13G-00094, A13G-00113, A13G-00191, A13G-00203, A13G-00205, A13G-00206, A13G-00207, A13G-00208, A13G-00209, A13G-00210, A13G-00211, A13G-00212, A13G-00213, A13G-00214, A13G-00216, A13G-00217, A13G-00218, A13G-00219, A13G-00220, A13G-00221, A13G-00224, A13G-00225, A13G-00226, A13G-00227, A13G-00228, A13G-00229, A13G-00230, A13G-00231, A13G-00232, A13G-00233, A13G-00234, A13G-00235, A13G-00236, A13G-00237, A13G-00238, A13G-00239, A13G-00240, A13G-00241, A13G-00242, A13G-00243, A13G-00246, A13G-00247, A13G-00248, A13G-00249, A13G-00250, A13G-00251, A13G-00252, A13G-00253, A13G-00254, A13G-00255, A13G-00256, A13G-00257, A13G-00266, A13G-00267, A13G-00268, A13G-00269, A13G-00270, A13G-00271, A13G-00272, A13G-00273, A13G-00274, A13G-00275, A13G-00276, A13G-00278, A13G-00279, A13G-00280, A13G-00281, A13G-00282, A13G-00283, A13G-00284, A13G-00285, A13G-00286, A13G-00287, A13G-00290, A13G-00291, A13G-00292, A13G-00293, A13G-00295, A13G-00296, A13G-00297, A13G-00298, A13G-00300, A13G-00301, A13G-00302, A13G-00303, A13G-00304, A13G-00305, A13G-00306, A13G-00307, A13G-00308, A13G-00309, A13G-00311, A13G-00312, A13G-00313, A13G-00314, A13G-00315, A13G-00316, A13G-00317, A13G-00318, A13G-00319, A13G-00320, A13G-00321, A13G-00322, A13G-00323, A13G-00324, A13G-00326, A13G-00327, A13G-00328, A13G-00329, A13G-00330, A13G-00332, A13G-00333, A13G-00334, A13G-00335, A13G-00346, A13G-00347, A13G-00348, A13G-00349, A13G-00350, A13G-00351, A13G-00352, A13G-00354, A13G-00358, A13G-00360, A13G-00361, A13G-00362, A13G-00363, A13G-00364, A13G-00365, A13G-00366, A13G-00367, A13G-00368, A13G-00369, A13G-00370, A13G-00371, A13G-00372, A13G-00373, A13G-00374, A13G-00382, A13G-00383, A13G-00384, A13G-00385, A13G-00387, A13G-00388, A13G-00390, A13G-00391, A13G-00392, A13G-00393, A13G-00394, A13G-00395, A13G-00396, A13G-00397, A13G-00399, A13G-00401, A13G-00402, A13G-00405, A13G-00411, A13G-00412, A13G-00413, A13G-00414, A13G-00416, 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A13G-04808, A13G-04809, A13G-04810, A13G-04811, A13G-04812, A13G-04813, A13G-04815, A13G-04816, A13G-04817, A13G-04818, A13G-04819, A13G-04820, A13G-04821, A13G-04822, A13G-04823, A13G-04824, A13G-04825, A13G-04826, A13G-04827, A13G-04828, A13G-04829, A13G-04830, A13G-04831, A13G-04832, A13G-04833, A13G-04834, A13G-04835, A13G-04836, A13G-04837, A13G-04838, A13G-04839, A13G-04840, A13G-04841, A13G-04842, A13G-04843, A13G-04844, A13G-04845, A13G-04846, A13G-04847, A13G-04848, A13G-04849, A13G-04850, A13G-04851, A13G-04852, A13G-04853, A13G-04854, A13G-04855, A13G-04856, A13G-04857, A13G-04858, A13G-04859, A13G-04860, A13G-04861, A13G-04862, A13G-04863, A13G-04864, A13G-04865, A13G-04866, A13G-04867, A13G-04868, A13G-04869, A13G-04870, A13G-04871, A13G-04872, A13G-04873, A13G-04874, A13G-04875, A13G-04876, A13G-04877, A13G-04878, A13G-04879, A13G-04881, A13G-04882, A13G-04883, A13G-04884, A13G-04885, A13G-04886, A13G-04887, A13G-04888, A13G-04889, A13G-04890, A13G-04892, A13G-04893, A13G-04894, A13G-04895, A13G-04896, A13G-04897, A13G-04901, A13G-04902, A13G-04903, A13G-04904, A13G-04906, A13G-04907, A13G-04908, A13G-04909, A13G-04910, A13G-04911, A13G-04912, A13G-04913, A13G-04914, A13G-04915, A13G-04916, A13G-04917, A13G-04918, A13G-04919, A13G-04920, A13G-04921, A13G-04922, A13G-04923, A13G-04924, A13G-04951, A13G-04952, A13G-04953, A13G-04954, A13G-04955, A13G-04956, A13G-04957, A13G-04958, A13G-04959, A13G-04960, A13G-04961, A13G-04962, A13G-04963, A13G-04964, A13G-04965, A13G-04966, A13G-04967, A13G-04968, A13G-04969, A13G-04970, A13G-04971, A13G-04974, A13G-04975, A13G-04976, A13G-04977, A13G-04978, A13G-04980, A13G-04983, A13G-04985, A13G-04987, A13G-04988, A13G-04989, A13G-04990, A13G-04993, A13G-04996, A13G-04997, A13G-04999, A13G-05000, A13G-05001, A13G-05002, A13G-05003, A13G-05004, A13G-05005, A13G-05007, A13G-05008, A13G-05009, A13G-05010, A13G-05011, A13G-05012, A13G-05013, A13G-05014, A13G-05015, A13G-05016, A13G-05017, A13G-05019, A13G-05020, A13G-05021, A13G-05023, A13G-05024, A13G-05025, A13G-05030, A13G-05041, A13G-05042, A13G-05043, A13G-05044, A13G-05045, A13G-05046, A13G-05047, A13G-05048, A13G-05049, A13G-05050, A13G-05051, A13G-05053, A13G-05054, A13G-05060, A13G-05061, A13G-05063, A13G-05064, A13G-05065, A13G-05076, A13G-05078, A13G-05079, A13G-05080, A13G-05086, A13G-05087, A13G-05088, A13G-05089, A13G-05091, A13G-05092, A13G-05093, A13G-05094, A13G-05095, A13G-05096, A13G-05097, A13G-05098, A13G-05099, A13G-05100, A13G-05101, A13G-05102, A13G-05103, A13G-05104, A13G-05105, A13G-05106, A13G-05107, A13G-05108, A13G-05109, A13G-05110, A13G-05111, A13G-05112, A13G-05113, A13G-05114, A13G-05115, A13G-05116, A13G-05118, A13G-05119, A13G-05120, A13G-05121, A13G-05122, A13G-05123, A13G-05124, A13G-05125, A13G-05127, A13G-05128, A13G-05129, A13G-05130, A13G-05131, A13G-05132, A13G-05133, A13G-05134, A13G-05136, A13G-05137, A13G-05138, A13G-05139, A13G-05140, A13G-05141, A13G-05142, A13G-05143, A13G-05144, A13G-05145, A13G-05146, A13G-05147, A13G-05148, A13G-05149, A13G-05150, A13G-05159, A13G-05175, A13G-05181, A13G-05182, A13G-05184, A13G-05185, A13G-05186, A13G-05187, A13G-05188, A13G-05192, A13G-05193, A13G-05194, A13G-05195, A13G-05207, A13G-05208, A13G-05209, A13G-05210, A13G-05211, A13G-05213, A13G-05220, A13G-05222, A13G-05226, A13G-05231, A13G-05232, A13G-05241, A13G-05249. | Class II | Philips is recalling HeartStart Home and OnSite (HS1) automated external defibrillators (AEDs) because one or both contact pins may be contaminated by residue from the soldering process. This contamination could prevent an adequate connection between the pads cartridge and the AED. If poor contact between the pads cartridge and AED occurs, the device may be unable to deliver therapy in an emergency. | Philips Medical Systems North America Inc. |
| Drugs | Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43 | G85041 | Class III | Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate. | Pfizer Us Pharmaceutical Group |
| Devices | Part 475620 Intramedullary Bone Saw CAM Assembly Size 12mm, A unique and exclusive clinical instrument used to correct leg length, or rotational discrepancies in the femur. | Lot 669420 | Class II | Incorrect labeling on specific lots of the Intramedullary Bone Saw.The Saw Blade Assembly was identified as CAM Assembly. | Biomet, Inc. |
| Devices | Part 475625, Intramedullary Bone Saw, Cam Assembly Size 13 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur. | Lot 239430, 239450 | Class II | Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly. | Biomet, Inc. |
| Devices | Part 475630, Intramedullary Bone Saw, Cam Assembly Size 14 mm, The Biomet Intramedullary Bone Saw is a unique and exclusive clinical instrument that is used to correct leg length, or rotational discrepancies in the femur. | Lot 239470, 457450 | Class II | Incorrect labeling on specific lots of the Intramedullary Bone Saw. The Saw Blade Assembly was identified as CAM Assembly. | Biomet, Inc. |
| Devices | Philips HeartStart FR3 Automated External Defibrillator (AED), models 861388 and 861389. The HeartStart FR3 is a battery powered automated external defibrillator (AED) designed for use by responders who have been trained in Basic Life Support (BLS), Advanced Life Support (ALS), or another physician-authorized emergency medical response program. The HeartStart FR3 is used to treat suspected victims of ventricular fibrillation (VF), the most common cause of sudden cardiac arrest (SCA), and certain ventricular tachycardia (VTs). Both models are used with disposable defibrillator pads applied to potential victims of SCA with the following symptoms: -Unresponsiveness -Absence of normal breathing If in doubt, apply the pads. The HeartStart FR3 is intended for adults and children over 55 pounds (25 kg) or 8 years old. Both models 861388 and 861389 are also intended for children under 55 pounds (25 kg) or 8 years old when used with the optional Infant/Child Key. If the Infant/Child Key is not available, or you are uncertain of the child's age or weight, do not delay treatment. | Serial numbers of units distributed in the USA: C13A-00592, C13C-00131, C13C-00150, C13C-00270, C13C-00679, C13C-00681, C13C-00769, C13D-00048, C13D-00197, C13E-00088, C13E-00168, C13E-00234, C13E-00242, C13E-00245, C13E-00326, C13E-00340, C13E-00368, C13E-00372, C13E-00380, C13E-00382, C13E-00390, C13E-00406, C13E-00495, C13E-00507, C13E-00511, C13E-00516, C13E-00526, C13E-00537, C13F-00011, C13F-00012, C13F-00013, C13F-00022, C13F-00024, C13F-00027, C13F-00031, C13F-00032, C13F-00033, C13F-00035, C13F-00038, C13F-00043, C13F-00047, C13F-00053, C13F-00054, C13F-00059, C13F-00071, C13F-00077, C13F-00078, C13F-00102, C13F-00104, C13F-00110, C13F-00114, C13F-00118, C13F-00126, C13F-00131, C13F-00137, C13F-00138, C13F-00140, C13F-00143, C13F-00146, C13F-00148, C13F-00168, C13F-00172, C13F-00173, C13F-00174, C13F-00180, C13F-00181, C13F-00198, C13F-00202, C13F-00212, C13F-00214, C13F-00215, C13F-00217, C13F-00218, C13F-00224, C13F-00225, C13F-00227, C13F-00232, C13F-00233, C13F-00236, C13F-00238, C13F-00239, C13F-00240, C13F-00244, C13F-00246, C13F-00250, C13F-00255, C13F-00266, C13F-00273, C13F-00274, C13F-00275, C13F-00278, C13F-00284, C13F-00291, C13F-00294, C13F-00307, C13F-00309, C13F-00318, C13F-00321, C13F-00322, C13F-00323, C13F-00329, C13F-00330, C13F-00331, C13F-00332, C13F-00336, C13F-00348, C13F-00353, C13F-00468, C13F-00543, C13F-00559, C13F-00567, C13F-00578, C13F-00590, C13F-00593, C13F-00595, C13F-00599, C13F-00604, C13F-00607, C13F-00651, C13F-00778, C13G-00008, C13G-00010, C13G-00035, C13G-00056, C13G-00057, C13G-00282, C13G-00284, and C13H-00062. Serial numbers of units outside the USA: C13C-00004, C13C-00256, C13C-00305, C13C-00323, C13C-00608, C13C-00639, C13E-00009, C13E-00021, C13E-00036, C13E-00048, C13E-00057, C13E-00058, C13E-00065, C13E-00163, C13E-00250, C13E-00265, C13E-00273, C13E-00311, C13E-00323, C13E-00328, C13E-00339, C13E-00341, C13E-00345, C13E-00346, C13E-00349, C13E-00350, C13E-00351, C13E-00358, C13E-00393, C13E-00395, C13E-00404, C13E-00407, C13E-00409, C13E-00424, C13E-00437, C13E-00441, C13E-00452, C13E-00454, C13E-00455, C13E-00499, C13E-00503, C13E-00518, C13E-00527, C13E-00535, C13E-00548, C13F-00010, C13F-00280, C13F-00286, C13F-00293, C13F-00298, C13F-00302, C13F-00303, C13F-00305, C13F-00306, C13F-00316, C13F-00317, C13F-00343, C13F-00345, C13F-00346, C13F-00358, C13F-00363, C13F-00369, C13F-00371, C13F-00381, C13F-00385, C13F-00391, C13F-00400, C13F-00420, C13F-00424, C13F-00428, C13F-00436, C13F-00473, C13F-00498, C13F-00539, C13F-00565, C13F-00579, C13F-00580, C13F-00583, C13F-00586, C13F-00587, C13F-00606, C13F-00619, C13F-00627, C13F-00629, C13F-00649, C13F-00666, C13F-00668, C13F-00677, C13F-00678, C13F-00682, C13F-00685, C13F-00687, C13F-00726, C13F-00742, C13F-00746, C13F-00748, C13F-00755, C13F-00758, C13F-00760, C13F-00782, C13F-00797, C13F-00815, C13F-00870, C13F-00889, C13F-00896, C13F-00938, C13G-00026, C13G-00039, C13G-00084, C13G-00126, C13G-00132, C13G-00142, C13G-00237, C13G-00247, C13G-00293, C13G-00315, C13G-00331, C13G-00337, C13G-00345, C13G-00407, C13G-00435, C13G-00451, and C13H-00035. | Class II | Philip's is recalling HeartStart FR3 Automated External Defibrillator (AED) because the Printed Circuit Board (PCB), which contains the circuitry that supplies energy to the device, could become separated from the electrical contact points that hold the board in place. In the event the PCB becomes separated from the electrical contact points, the AED may not be ready to deliver a shock in the event of an emergency. | Philips Medical Systems North America Inc. |
| Devices | Rusch Brochopart and Rusch Brochopart White The Rush Endobronchial Tube set is indicated for uses commonly associated with oral endobronchial tubes, including, but not limited to, thoracic surgery, bronchospirometry, administration of endobronchial anesthesia, etc. The endobronchial tube allows ventilation and selective inflation or deflation of either lung. | Product Code - 116200260, Batch 09LE51, 10GE31, 11LE42, 12DE17, 12IE37, 13CT26, 13DT32; Product Code - 116200280 - Batch 09HE34, 09JE41, 10BE07, 11HE33, 11JE41, 13ET12; Product Code - 116200350 - Batch 0918M, 0915M, 09JE43, 09JE42, 0917M, 11AE03, 11DE15, 11GE27, 09HE34, 11JE43, 11JE42, 12AE02, 12BE07, 12DE17, 12EE19, 12GE27, 12HE33, 13AE01, 13CT26, 13DT33, 13ET12; Product Code 116200370 - Batch 0915M, 0917M, 0914M, 09JE41, 09JE43, 11DE15, 11EE20, 11GE27, 11JE42, 11HE32, 11JE43, 11IE39, 12AE01, 12AE03, 12GE31, 12BE06, 12DE18, 12IE39, 12JE44, 13AT44, 13BT44, 13AE01, 12LE49, 13DT33; Product Code 116200390 - Batch 0914M, 0922M, 0917M, 09JE44, 09FE23, 09HE35, 09JE42, 10GE29, 10AE02, 09JE43, 09KE46, 09LE51, 10AE01, 10CE11, 10DE18, 10EE19, 10JE41, 10EE20, 11DE15, 11KE42, 11GE30, 11HH33, 11IE37, 11IE38, 11IE39, 13AT36, 13BT25, 13BT29; Product Code 116200410 - Batch 0922M, 0915M, 0918M, 09IE36, 09JE43, 10AE05, 10BE06, 10DE16, 10GE28, 10JE41, 11DE15, 11GE27, 11HE34, 11JE43, 13BT44, 13DT32; Product Code 116201350 - Batch 0921M, 09JE40, 09FE23, 13GT05; Product Code 116201370 - Batch 0922M, 0915M, 13AE01, 13ET18, 13HT12, 09FE24; Product Code 116201390 - Batch 09JE44, 10CE10; Product Code 116201410 - Batch 10KE47 | Class II | The product may fail to achieve seal of right lung due to the cuff inflating to one side | Teleflex Medical |
| Drugs | Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001 | 211J3291 211J3292 211K3293 211K3294 211K3295 211K3297 211K3298 211K3299 211K3301 211K3302 211K3315 211K3321 211K3322 | Class II | Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin. | Traxx International Corp |
| Food | Starbuck's brand Greek Yogurt Raspberry & Lemon Parfait; 6.1 oz single serve plastic cups, sold as individual unit. Finished product label is affixed to the top of the cup; nutritional labeling is located on the side of the cup, along with the printed code which appears on a white sticky label. UPC 6211198649. | "Enjoy by 03 05", which represents March 5th, 2014. | Class I | Gretchen's Shoebox Express is recalling Greek Yogurt Raspberry & Lemon Parfait cups sold under the Starbucks brand due to undeclared egg. | Gretchen's Shoebox Express |
| Devices | Philips Model EPIQ 5 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis. | All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014). | Class II | A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value. | Philips Medical Systems North America Inc. |
| Devices | Philips Model EPIQ 7 Ultrasound System. Intended for diagnostic ultrasound imaging and fluid flow analysis. Catalogue numbers 795200 / 795201 / 795202 / 795204 / 795205 / 795206 EPIQ is intended for diagnostic ultrasound imaging and fluid flow analysis. The collection of Doppler velocity results values are used to assist in diagnosing the existence, location and severity of cardiac or vasculare stenosis. | All systems below software v1.1.2 Which includes software v1 and v 1.1 (All lot codes shipped prior to 2/28/2014). | Class II | A problem has been detected with Philips Model EPIQ 5 and 7 Ultrasound System. The system will report incorrect Doppler velocities if you use High Pulse Repetition Frequency (HPRF) with multiple sample volume gates. While in High Pulse Repetition Frequency (HPRF) in Display Zoom Velocity Scale using manual spectral Doppler trace, the velocities in the velocity results table may be overstated by 25-75%, depending on the scale value. | Philips Medical Systems North America Inc. |
| Devices | DeRoyal(R) LIMB HOLDERS, COTTON ADJUSTABLE, UNIVERSAL, REF M2017 Product Usage: Limb holders are intended for mildly to moderate agitated or disoriented patients who disrupt medical treatment and/or cause harm to themselves and/or others | lot numbers 1143442 and 1161762 | Class II | Moldy smell in product | DeRoyal Industries Inc |
| Devices | Halogen Lamp component in RetCam 3 System - Clarity Medical Systems, Inc; Pleasanton, CA. General ophthalmic imaging including retinal, corneal and external imaging. Photo-documentation of pediatric ocular diseases including retinopathy of prematurity. Screening for Type-2 re-threshold retinopathy of prematurity or treatment requiring ROP. | Lot of Halogan Lamp Component is #020612C. RetCam 3, Part number 21-100500. RetCam 3 affected serial numbers: RC3066 RC3079 RC6013 RC6033 RC6034 RC6035 RC6036 RC6037 RC6038 RC6039 RC6040 RC6041 RC6043 RC6044 RC6045 RC6047 RC6049 RC6050 RC6053 RC6054 RC6055 RC6056 RC6057 RC6058 RC6059 RC6060 RC6063 RC6064 RC6066 RC6067 RC6068 RC6069 RC6070 RC6071 RC6072 RC6073 RC6074 RC6075 RC6076 RC6077 RC6078 RC6079 RC6080 RC6081 RC6082 RC6083 RC6084 RC6085 RC6086 RC6087 RC6088 RC6089 RC6090 RC6092 RC6093 RC6094 RC6095 RC6096 RC6098 RC6099 RC6101 RC6102 RC6103 RC6104 RC6105 RC6106 RC6107 RC6108 RC6109 RC6110 RC6111 RC6112 RC6113 RC6301 RC6302 RC6303 RC6304 RC6305 RC6306 RC6307 RC6309 RC6310 RC6311 RC6312 RC6313 RC6314 RC6315 RC6316 RC6317 RC6318 RC6319 RC6320 RC6321 RC6322 RC6323 RC6324 RC6325 RC6326 RC6327 RC6328 RC6329 RC6330 RC6331 RC6332 RC6333 RC6334 RC6335 RC6336 RC6337 RC6338 RC6339 RC6340 RC6341 RC6342 RC6343 RC6344 RC6364 | Class II | One lot of Halogen lamps have the potential to fail sooner than the expected life of the lamp which could result in damage limited to the internal electrical components inside the RetCam 3 computer module. | Clarity Medical Systems Inc |
| Biologics | Cornea | 126688OSC; | Class III | Human cornea, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, was distributed. | San Diego Eye Bank |
| Biologics | Reagent Red Blood Cells | V139824; V139825 | Class III | Misbranded Reagent Red Blood Cells were distributed. | Alba Bioscience Limited |
| Drugs | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3. | Lot #69618, Exp. 09/14 | Class II | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. | Noven Pharmaceuticals, Inc. |
| Drugs | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3. | Lot #70132, Exp. 09/14 | Class II | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. | Noven Pharmaceuticals, Inc. |
| Food | High Mowing Organic Sprouting Seeds Ancient Eastern Blend , 4 oz. resealable plastic bag UPC Code: 872724005445 | Lot code: MUM19-10 | Class II | Contains undeclared wheat | High Mowing Organic Seed |
| Drugs | Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01 | 2013313915 Exp 08/15, 2013374398 Exp 09/15, 2013323969 Exp 08/15, 2013364336 Exp 09/15, 2013323971 Exp 08/15, 2013364334 Exp 09/15, 2013313913 Exp 08/15 | Class II | Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml. | Paddock Laboratories, LLC |
| Drugs | Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10 | Lot #: 91357 | Class III | Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. | McKesson Packaging Services |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
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Wednesday, March 26, 2014
FDA Enforcement Report Week of March 26, 2014 for Drugs
| Drugs | Clalis capsules, 50 mg, 6 -count bottle ( labeling is in foreign language) | All lots | Class I | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient. | Fabscout Entertainment, Inc |
| Drugs | Silver Sword capsules, 180 mg, 16-count clamshell tin, UPC 1 234658 970128 12345 (labeling is in foreign language) | All lots | Class I | Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined that the products was found to contain sildenafil, an undeclared active pharmaceutical ingredient. | Fabscout Entertainment, Inc |
| Drugs | Marcaine (bupivacaine HCl) injection, USP, 0.25%, 30 mL single-dose vials-preservative free, packaged in 10-count vials per carton, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-1559-30. | Lot 25-220-DD, Exp 1JAN2015 | Class I | Presence of Particulate Matter: Units of this lot may have visible metal particles embedded in the vial and in the solution causing the product to be discolored. | Hospira Inc. |
| Drugs | 5% Dextrose Injection, USP, 100 mL Single dose VIAFLEX plastic containers, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, Product code 2B0089, NDC 0338-0017-38. | Lot #: P285288, Exp 11/13 | Class I | Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution. | Baxter Healthcare Corp. |
| Drugs | 0.9% Sodium Chloride Injection, USP, packaged in a) 50 mL Single dose VIAFLEX plastic containers (Product code 2B1308, NDC 0338-0049-31) and b) 100 mL Single dose VIAFLEX plastic containers (Product code 2B1302, NDC 0338-0049-18) and (Product code 2B1309, NDC 0338-0049-38), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA. | Lot #: a) P297283, Exp 08/14; b) P292326, Exp 04/14; P293993, Exp 05/14; and P293514, Exp 04/14 | Class I | Presence of Particulate Matter: Baxter is issuing a voluntary recall for these IV solutions due to particulate matter found in the solution. | Baxter Healthcare Corp. |
| Drugs | Clinimix 4.25/25 sulfite-free (4.25% Amino Acid in 25% Dextrose) Injection, 1000 mLCLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1115-04. | Lot#: P287045, Exp 6/2014 | Class I | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. |
| Drugs | Clinimix E 4.25/10 sulfite-free (4.25% Amino Acid with Electrolytes in 10% Dextrose with Calcium) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC 0338-1115-04. | Lot#: P275883, Exp 10/2013 | Class I | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. |
| Drugs | Clinimix 5/15 sulfite-free (5% Amino Acid in 15% Dextrose) Injection, 2000 mL CLARITY Dual Chamber Container bag, Rx only. Dist: Baxter Healthcare Corporation, One Baxter Parkway, Deerfield, IL 60015. NDC: 0338-1099-04. | Lot# P285122, Exp 5/2014 | Class I | Presence of Particulate Matter: Particulate matter includes wood, sodium citrate and dextrose. | Baxter Healthcare Corp. |
| Drugs | Hydroxyprogesterone Caproate 250mg/ml in Sesame Oil, 1 ml injectable solution, in 3 ml single dose syringes; a multi-ingredient compounded medication in bulk, containing Benzoyl Benzoate USP 0.46 ml/1ml, and Benzyl Alcohol 0.02 ml/1ml; syringe is labeled in part ***FOR INJECTION USE ONLY***RX South LLC DBA RX3 12230 Iron Bridge Rd Chester, VA 23831*** | Lot number: 12052013:03 Expiration date: 06/03/2014 | Class II | Crystallization; visible crystals from the active ingredient formed due to extreme cold temperatures during shipping | RX South LLC DBA RX3 Pharmacy |
| Drugs | Advil PM Caplets, (Ibuprofen, 200 mg /Diphenhydramine citrate, 38 mg) 120 count bottle, OTC, Pfizer, Madison, NJ 07940 USA. NDC 0573-0164-43 | G85041 | Class III | Subpotent Drug: This lot is being recalled because of out-of-specification test results for Diphenhydramine citrate. | Pfizer Us Pharmaceutical Group |
| Drugs | Guaifenesin USP, 50 Kg Drums, CAS No. 93-14-1, Reg. No. 05436, Caution: For Manufacturing, Processing, or Repacking, Delta Synthetic Co., Ltd. 15, Minsheng St., Tucheng Dist., New Taipei City, 23679, Taiwan (ROC), NDC 60203-1001 | 211J3291 211J3292 211K3293 211K3294 211K3295 211K3297 211K3298 211K3299 211K3301 211K3302 211K3315 211K3321 211K3322 | Class II | Presence of Foreign Matter: Guaifenesin API powder is being recalled due to the possibility that the product contains polyethylene fibers from a screen used to sift the Guaifenesin. | Traxx International Corp |
| Drugs | Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3. | Lot #69618, Exp. 09/14 | Class II | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. | Noven Pharmaceuticals, Inc. |
| Drugs | Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3. | Lot #70132, Exp. 09/14 | Class II | Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained. | Noven Pharmaceuticals, Inc. |
| Drugs | Perrigo, Clindamycin Palmitate Hydrochloride for Oral Solution, USP, 75mg/5mL, 100 ml, NDC 0574-0129-01 | 2013313915 Exp 08/15, 2013374398 Exp 09/15, 2013323969 Exp 08/15, 2013364336 Exp 09/15, 2013323971 Exp 08/15, 2013364334 Exp 09/15, 2013313913 Exp 08/15 | Class II | Presence of Particulate Matter Perrigo is recalling seven lots of Clindamycin Palmitate Hydrochloride for Oral Solution 75mg/5ml. | Paddock Laboratories, LLC |
| Drugs | Venlafaxine Hydrochloride, Extended Release Capsules, 150 mg, UD-100 Tablets per Box (10 x 10), Rx Only, Manufactured by: Teva Pharmaceuticals USA, 1090 Horsham Rd, North Wales, PA 19454, NDC 63739-0512-10 | Lot #: 91357 | Class III | Failed Dissolution Specification: Out of Specification dissolution results at 12 month interval. | McKesson Packaging Services |
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