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U.S. Department of Health and Human Services

Enforcement Report - Week of March 26, 2014

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Source Plasma 0530394149; 053039394; 0530393697; 0530393535; 0530392892; 0530392693; 0530392001; 0530391617; 0530391505; 0530391141; 0530390944; 0530387218; 0530386449; 0530386279; 0530385856; 0530385694; 0530385242; 0530385039; 0530384740; 0530384530; 0530383951; 0530383876; 0530383451; 053050260; 053050252; 053050223; 053050190; 053050212; 05305146; 053050104; 053050065; 053050039; 053050022; 053041868; 053041922; 053041862; 053041843; 053041815; 053041795; 053041766; 053041746. Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. CSL Plasma
Biologics Platelets Pheresis Leukocytes Reduced 103020207- part 1; 103020207- part 2 Class III Blood products, exposed to unacceptable temperature during storage, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 103363993- part 1; 103363993- part 2; 103363994- part 1; 103363994- part 2 Class III Blood products, exposed to unacceptable temperature during storage, were distributed. Blood Systems, Inc.
Biologics Red Blood Cells Leukocytes Reduced 103363995; 103363996; 103363997; 103367002; 103367003 Class III Blood products, exposed to unacceptable temperature during storage, were distributed. Blood Systems, Inc.
Devices SL & SLi Series (Mod 15/18/20/25) Linear Accelerator Used for radiation therapy treatments of malignant neoplastics diseases. 105285, 105445, 105305, 105532, 105366, 105403, 105265, 105492, 105273, 105186, 105494, 105481, 105395, 105326, 105467, 105392, 105204, 105382, 105093, 105521, 105154, 105387, 105228, 105126, 105514, 105359, 105279, 105518, 105528, 105210, 105482, 105213, 105466, 105284, 105544, 105260, 105194, 105195, 105515, 105386, 105199, 105475, 105117, 105325, 105127, 105498, 105233, 105187, 105478, 105261,  ...
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Class II Customers are resetting the default values outside recommended factory settings. Elekta, Inc.
Food GOKNUR Organic Frozen/IQF Pomegranate Arils. Packed in 10 kg cases. Labeling is bilingual and in English, reads in part:"goknur***Product of Turkey***ORGANIC FROZEN/IQF POMEGRANATE ARILS***Production Date 17.10.2012***Lot No 12-15-13-2-1-O***Net Weight (kg) 10***Crop Year 2012***Expiry Date 17.10.2014***Carton No 8721***". Lot Code 12-15-13-2-1-O Production Date 17.10.2012 Crop Year 2012 Carton No. 8721 Class I Purely Pomegranate, Inc. is voluntarily recalling certain lots of a pomegranate arils due to public concerns about the Hepatitis A Virus. Purely Pomegranate, Inc
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  ...
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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  ...
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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,  ...
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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  ...
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Class II GE 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,  ...
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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,  ...
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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,  ...
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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
Devices 2.5MM Aggressive Blade Known as a Sinuscopic Shaver Blade, this device is composed of a metal cutter and plastic drive shaft that goes into a metal housing supported by a plastic hub. ENT Precision Cutter, Aggressive, ESSxlHUMMER 4, Rx Only It is used for ENT procedures and functions by means of rotation when adapted to a handpiece and console. Through the rotation, the necessary tissue is resected as required by the user. The blade housing has an etching line guide that starts with a straight line and along with a scale from 1cm to 7cm in 1cm increments that serves the doctor as a guide by indicating how far the device is being introduced into the surgical area. P/N 5290-628-000, Lot #13280CG2 Class II Stryker Instruments is voluntarily recalling the single use 2.5MM Aggressive Blade because the line on the affected part (P/N 5290-928-000, Lot #13280CG2) was a straight line without a number scale or logo. The line required for this part number includes a number scale that goes from 1cm  7cm. Stryker Instruments Div. of Stryker Corporation
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