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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Handset component of the Handicare USA's Minivator Bath Bliss Reclining Bath Lifts (Bath Bliss), Part Number BP300-100/BP300-400RSUS (handset) - Model Numbers BBR0311USAB (blue) and BBR0311USSS (silver) Handset component devices operate the Minivator Bath Bliss Reclining Bath Lift, a non-AC-powered patient lift consisting of a motorized actuator, powered mechanical seating device, temporarily secured in a bath, and used to lift and lower a patient in the vertical or reclining position while bathing. Handsets shipped with Bath Lifts belonging to the following serial numbers: BH05100001 - BH05129999 and BH06120001 - BH11129999; Handsets shipped as spare parts with the following serial numbers: BS05100001 - BS05129999 and BS06120001 - BS11129999. Class II Firm became aware that two handsets in the affected batches became inoperable while the user was in the tub. Handicare Accessibility
Devices Siemens RAD Fluoro Uro Systems - Luminos dRF, Ysio and Uroskop Omnia with software versions VB10D, VB10F, VB10C and VB10E. Fluroscopic X-Ray Systems Material 10094910, with serial numbers 1036, 1045, 1025, 1040, 1041, 1032, 1047 and 1035; Material 10281013, with serial numbers 21221, 21223, 21213, 21089, 21098, 21163, 21171, 21194, 21212, 21186, 21188, 21167, 21187 and 21189; Material 10281163, with serial number 31114. Class II Siemens has discovered through product monitoring a potential malfunction when using system operating with software versions VB10D, VB10F, VB10C and VB10. During a RAD examination the possibility exists that radiation may continue longer than expected and may result in unnecessary dose applied during an acquisition. Additionally, it is not possible for the user to stop the radiation manually; however, there are emergency circuits active which will stop radiation through another independent mechanism. If the image quality of the overexposed image is unacceptable for diagnosis, the examination could potentially have to be repeated. The upgrade to software version VB10G resolves this potential malfunction. For patients who were treated with affected systems in the past, no measures such as additional treatment or aftercare are necessary. Siemens Medical Solutions USA, Inc
Devices DRX Revolution, Catalog #'s 1)1019397, 2) 1023415 (w/ installation warranty, US-only) and 3) 1023423 (w/ parts warranty, US-only). The device is designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas Serial Numbers: All serial numbers manufactured since inception in June 21, 2012 until June 12, 2013 Class II Carestream Health Inc. is conducting a recall for the Column end Cover present on the DRX Revolution Mobile X-Ray System due to the cover dislodging from the column. Carestream Health Inc.
Biologics Red Blood Cells 2497273; Class II Blood product, collected from a donor whose suitability to donate was not adequately determined, was distributed. OneBlood, Inc.
Biologics Platelets Pooled Leukocytes Reduced W036812853139; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Fresh Frozen Plasma W036813024156; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. OneBlood, Inc.
Biologics Red Blood Cells W036813024156; 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 W140912244791; Class II Blood products, collected from a donor who reported high risk behavior, were distributed. South Texas Blood & Tissue Center
Biologics Blood and Blood Products for Reprocessing W140912244791; Class II Blood products, collected from a donor who reported high risk behavior, were distributed. South Texas Blood & Tissue Center
Devices Stereotactic Circular Collimator - 3D Line stereotatic Hardware Accessories The device is part of the class of medical devices that are used in radiotherapy for the treatments of head tumors. 933, 935, 936, 937, 940, 843, 844, 845, 846, 847, 833, 834, 835, 836, 837, 801, 802, 803, 804, 805, 908, 909, 910, 911, 912, 889, 890, 891, 892, 893, 894, 848, 849, 850, 851, 852, 853, 974, 975, 976, 977, 978, 1032, 1033, 1034, 928, 929, 930, 931, 932,  ...
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Class II Potential for clinical errors. Elekta, Inc.
Biologics Cornea 2009243C; 2009244C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 201023C; 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. Lions Eye Bank For Long Island
Biologics Cornea 201053C; 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. Lions Eye Bank For Long Island
Biologics Cornea 201015C 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. Lions Eye Bank For Long Island
Biologics Cornea 1301589ODC Class II Human Cornea, recovered from a donor who was not properly assess for hemodilution, was distributed. Donor Network of Arizona
Biologics Cornea 200949C; 200950C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2009185C; 2009186C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 201047C; 201048C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 201045C 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. Lions Eye Bank For Long Island
Biologics Cornea 2010121C; 2010122C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2010157C; 2010158C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 201062C Class II 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. Lions Eye Bank For Long Island
Biologics Cornea 201057C; 201058C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 201059C; 201060C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2010345C; 2010346C Class II Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2010263C; 2010264C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2010255C; 2010256C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2010243C; 2010244C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea CW102297OD; CW102297OS Class III Human Corneas, recovered from a donor who was improperly assessed for hemodilution, were distributed. Eye Bank Of Wisconsin, Inc.
Biologics Cornea 2010313C 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. Lions Eye Bank For Long Island
Biologics Cornea 201049C 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. Lions Eye Bank For Long Island
Biologics Cornea 2009227C; 2009228C; Class III Human tissue allografts, 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, were distributed. Lions Eye Bank For Long Island
Biologics Sclera 2009227SB; 2009227SC Class III Human tissue allografts, 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, were distributed. Lions Eye Bank For Long Island
Drugs Extended Phenytoin Sodium Capsules, USP, 100 mg, 1000 CAPSULES, Rx only, amneal PHARMACEUTICALS label, NDC 65162-212-11 --- Manufactured by: Amneal Pharmaceuticals of NY Hauppauge, NY 11788 Distributed by: Amneal Pharmaceuticals Glasgow, KY 42141 Batch/Lot HL50611, exp. 1/2014 Class II Failed dissolution specifications; 18 month CRT Amneal Pharmaceuticals of New York, LLC.
Veterinary Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 26 to 50 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX. VETIQ HeartShield Plus (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 26 to 50 lbs. ANADA 200-302. NDC 49994-205-06. Manufactured for: TruRX, LLC, Eagle, ID. Worm Shield (ivermectin/pyrantel) Flavored Chewables, 136 mcg Ivermectin and 114 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs 26-50 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR. Virbac Iverhart Plus Lot numbers and expiration dates of recalled product  ...
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Class III The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency. Virbac Corporation
Veterinary Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51 to 100 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX. VETIQ HeartShield Plus (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51 to 100 lbs. ANADA 200-302. NDC 49994-305-06. Manufactured for: TruRX, LLC, Eagle, ID. Worm Shield (ivermectin/pyrantel) Flavored Chewables, 272 mcg Ivermectin and 227 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs 51-100 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR. Lot numbers and expiration dates of recalled product failing ivermectin potency: Iverhart Plus- 111394, exp 12/2013; 120091, exp 01/2014; 120377, exp 03/2014; 120440, exp 04/2014120651, exp 04/2014; 120658, exp 05/2014; 120824, exp 06/2014  ...
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Class III The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency. Virbac Corporation
Veterinary Virbac Iverhart Plus (ivermectin/pyrantel) Flavored Chewables, 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs up to 25 lbs. ANADA 200-302. Manufactured by Virbac A, Inc, Fort Worth, TX. VETIQ Heart Shield plus (ivermectin/pyrantel), 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/box, Recommended for dogs up to 25 lbs. Packaged 6 flavored chewables per blister pack. ANADA 200-302, NDC 49994-105-06. Manufactured for: TruRx, LLC, Eagle, ID. Worm Shield (ivermectin/pyrantel) Flavored Chewables, 68 mcg Ivermectin and 57 mg pyrantel as pamoate salt, 6 chewables/blister pack, Recommended for dogs up to 25 lbs. ANADA 200-302. Manufactured for: Schuyler LLC, Portland, OR. Lot numbers and expiration dates of recalled product failing ivermectin potency: Iverhart Plus- 120092, 10/2013; 120397, 12/2013 and 120398, 11/2013. Wormshield- 120397, 12.2013. Heartshield- NONE Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: Iverhart Plus- 120195, 02/2014 and 120798, 02/2014. Wormshield- 120195, 02/2014. Heartshield- 120798, 02/2014. Class III The products were identified during an ongoing investigation and testing as being out-of-specification for Ivermectin potency. Virbac Corporation
Biologics Red Blood Cells W072011004019; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Kaiser Foundation Hospital
Biologics Plasma Frozen within 24 hours (FP24) W072011004019; Class II Blood products, collected from a donor considered to be at increased risk for variant Creutzfeldt-Jakob Disease (vCJD), were distributed. Kaiser Foundation Hospital
Biologics Platelets Pheresis Leukocytes Reduced W071813010687; Class II Blood product, labeled as leukoreduced without the assurance that it met the criteria for a leukoreduced product, was distributed. Southern California Permanente Medical Group Blood Donor Ctr
Devices MLS Torpedo Mini-Light Ophthalmic single-port illumination. Sutureless 25- gauge illuminator for vitreo-retinal surgery when full field illumination of bimanual surgery if desired. Part Number Lot Number Expiration 11007 M52934 04/2013 11017 M53017 04/2013 11007 M55285 07/2013 11007 M55869 08/2013 11007 M58610 12/2013 11007 M59575 02/2014 11007 M61781 05/2014 Class II The product was registered and distributed as a Class I medical device and was subsequently determined to be a Class II medical device which requires FDA market clearance. Insight Instruments, Inc.
Devices DRX- Revolution, Catalog number: 101937, 1023415 & 1023423. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients Model: DRXR-1 Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware Class II Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure Mode (NEM) image is taken immediately prior to an Extended Exposure Mode (EEM) image with the system in Fast Preview Mode. Investigation revealed that the DirectView version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware contained a timing issue which could result in a non-diagnostic image. Carestream Health Inc.
Devices CARESTREAM DRX -Mobile Retrofit Kit, Catalog number: 1019397. Made in U.S.A. by Carestream Health, Inc. 150 Verona Street Rochester, NY 14608 to perform radiographic x-ray examinations on all pediatric and adult patients Model: DRX Mobile Serial numbers: all serial numbers manufactured with version 5.5 software and version 69 firmware Class II Carestream Health Inc. has conducted a voluntary field action which includes the installation of a software patch on the following: DRX-Revolution Mobile X-Ray, DRX-Mobile and DRX Transportable Systems with DirectView Version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware. Carestream recently received reports of a non-diagnostic image on exams when a Normal Exposure Mode (NEM) image is taken immediately prior to an Extended Exposure Mode (EEM) image with the system in Fast Preview Mode. Investigation revealed that the DirectView version 5.5 and 5.6 console software when used with DRX-1 Detector version 69 firmware contained a timing issue which could result in a non-diagnostic image. Carestream Health Inc.
Biologics Cornea 2011233C; 2011234C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2011239C; 2011240C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2011153C; 2011154C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 201117C; 201118C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2010399C; 2010400C Class II Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2010372C; 2010371C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 201005C; 201006C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Biologics Cornea 2010381C 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. Lions Eye Bank For Long Island
Biologics Cornea 2011285C; 2011286C Class III Human corneas, 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, were distributed. Lions Eye Bank For Long Island
Devices Bayer brand A1CNow+ MULTI-TEST A1C SYSTEM TEST KITS (PART NUMBER 3021/08842610); Hemoglobin A1c Monitor; Glycosylated Hemoglobin Assay; Product is manufactured and distributed by Bayer HealthCare LLC, Sunnyvale, CA The A1CNow+ test provides quantitative measurement of the percent of glycated hemoglobin (%HbA1c or %A1C) levels in capillary (fingerstick) or venous whole blood samples. The test is for professional use to monitor glycemic control in people with diabetes. Lot: 1300733 (US, China); Lot: 1300712 (Argentina, Uruguay); Lots: 1300711, 130012 (Japan) Class II Test results from these lots may produce a high-bias reading (by up to 20%) that is outside of limits defined for stability and product accuracy when product is stored at room temperature four (4) to five (5) months after release. Bayer Healthcare Llc
Devices Edwards Lifesciences Fem-Flex Femoral Arterial Cannula with Duraflo Coating, DIITFA02225, Sterile, RX only For Single Use Only, Product Usage: Edwards Lifesciences femoral access cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Femoral access cannulae may be used in pediatric populations or adult populations based on flow rate requirements and individual patient anatomy. Please consult labeling to determine pressure drop related to flow rates. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Lot number 59388992 expiry 1/1/16 Class II Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation. Edwards Lifesciences, LLC
Devices Edwards Lifesciences Dispersion Aortic Perfusion Cannula with Duraflo Coating, Sterile, RX only For Single Use Only, Product Usage: Aortic perfusion cannulae are intended for perfusion of the ascending aorta during short-term (< 6 hours) cardiopulmonary bypass procedures. Aortic cannulae in sizes 6Fr to 18Fr can be used in pediatric patient populations. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin coated blood path is desired. Lot number 59261626 expiry 06/01/15 Class II Edwards Lifesciences is recalling two lots of Duraflo Cannulas due to reported complaints involving cracks in the t-connector of the devices which were confirmed during product evaluation. Edwards Lifesciences, LLC
Devices ADVIA Centaur Intact PTH Calibrator (6 pack); Catalog Number: SMN 10492387 For in vitro diagnostic use in calibrating Intact PTH assays on the ADVIA Centaur Systems. Kit Lot: 14136A16 04 Mar 2014 Class III PTH Calibrator packaged with only high calibrator. Siemens Healthcare Diagnostics, Inc
Devices Harmony Equipment Management System, Model #603X/80XX, STERIS Corporation, Mentor, OH Harmony Equipment Management Systems (EMS) are used in hospital facilities to provide ready access to medical gasses, electrical power and audio/visual data services, in addition to managing surgical support equipment such as endoscopic equipment, cautery devices and insufflators. Serial numbers 0422503114 - 0426604096 Class II Dräger Medical GmbH has notified STERIS of the potential for a break in the drive screw contained in the motorized ceiling supply unit, a component of the Harmony EMS system. The ceiling supply unit controls the motorized adjustment of the height and rotation of the supply column. Should a break occur in the drive screw, there is potential for the adjustable arm to drop down, causing the EMS system to lower unexpectedly. Steris Corporation
Veterinary Bio-Cox Granular 60 Alpharma Brand of salinomycin sodium Type A Medicated Article Net Wt 50 LB, Marketed by Alpharma Inc. Bridgewater, New Jersey 08807, NADA # 128-686 HSK10293, HSK10294, HSK10295, HSK10296, HSK10297, HSK10298, HSK10299, HSK10300, HSK10301, HSK10302, HSK10303, HSK10304, HSK10305, HSK10306, HSK10307, and HSK10308. Class II Stability failure Zoetis Inc
Devices Pinook Mini Massager Distributed by www.pinookusa.com. Used to strengthen the abdominal muscles. ALL LOTS Class II Failure to submit a premarket submission and gain approval of a medical device. Pinook-Usa
Devices Pinook Micro Massager Distributed by www.pinookusa.com Used to strengthen the abdominal muscles. ALL LOTS Class II Failure to submit a premarket submission and gain approval of a medical device. Pinook-Usa
Devices Ti-Magna Fx Washer Ti-Versa-FX®II Femoral Fixation System S/C Plates The compression tube/plates of this trauma system are used with Ti-Versa-Fx® II Femoral Fixation System lag screws for the internal fixation of proximal femoral and supracondylar fractures. The Ti-Magna Fx System is an osteosynthesis item for orthopedic use in open internal fixation of fractures of the femoral neck, condyle, or tibia, etc. The washer prevents the screw head from being buried in the bone. 00365888 00366414 60004449 60146383 60186345 60197210 60208698 60282431 60389889 60405108 60407931 60869220 61080693 61327948 61375455 61754656 61923922 60004450 60208699 60276711 60282432 60869221 61080694 61391007 60024174 61080695 61328382 61375457 61421602 24416600 60084846 60154683 60186372 60197211 60199098 60266079 60266080 60279692 60373565 60405109 60407932 60415506 60428806 60586953 60725599 61041311 61261269 61287734 61309831 61391008 61698392 61732770 61933545 60024175 60146386 60186373 60197212 60208702 61041313 61375459 61505519 61895287 62020570 60390423 60407933 60855531 60855535 60855536 60855537 61261270 23318000 23349600 60065066 60088732 60118716 60126399 60137449 60150012 60160727 60252568 60282398 60321685 60341615 60373346 60407903 60415261 60463630 60582482 60629012 60665668 60665669 60676030 60830532 60926411 60982760 61041155 61041156 61052948 61079688 61088994 61228687 61426136 61559639 61599273 61683731 61732260 61765106 61804102 61829985 61853628 61885960 61926992 61992671 62058073 62152073 62157809 Class II Zimmer recently conducted a review of historic packaging validations completed. Based on this review, it was determined that a subset of product packaged at a single Zimmer facility required testing to ensure that previously packaged product from this facility met the established requirements for sterile barrier integrity. The number of samples required for packaging testing, to provide statistical confidence (90% confidence in 99% reliability), were not available for the Ti MagnaFx Washer and Ti VersaFx S/C 90 degree and 95 degree plates. A voluntary recall will be conducted of all potentially affected products. The voluntary recall is limited to Japan as these products are distributed only in Japan Zimmer, Inc.
Food Creafuse Grape, 600 Grams 4568 Class II Product contains 1,3 dimethylamylamine (DMAA) GE PHARMA LLC -
Food Creafuse Fruit Punch, 600 Grams 4570 Class II Product contains 1,3 dimethylamylamine (DMAA) GE PHARMA LLC -
Devices COBAS INTEGRA 800 Analyzer with software 9864.C2 Cobas. COBAS Part Numbers 28122474001, 28122474692, 04559126001, 04589459970 corresponding to the Analyzer with or without closed tube sampling accessory A fully automated system for clinical chemistry analysis intended for the in vitro quantitative/qualitative determination of analytes in body fluids. software version 9864.C2 Class II Roche COBAS INTEGRA 800 system, Software Version 9864.C2 does not perform necessary ISE Service Actions. Whenever the ISE rack is removed, the ISE counters in the software are reset to zero and the corresponding Service Actions are not conducted automatically by the system. Additionally, certain maintenance activities that have to be performed manually by the operator are not requested on the software by the due date. This software issue ONLY affects systems performing ISE tests. Roche Diagnostics Operations, Inc.
Devices Dual Luer Lock Cap The device is intended for use as a cap for male or female Luer ports on medical devices such as manifolds, stopcocks or sets. 10043, 10044 Class II The firm is recalling lots 10043 and 10044 due to loose particulate matter found in the packaging. Particulate matter entering the fluid path from the Luer lock caps may result in embolic events. Baxter Healthcare Corp.
Devices ISE REF Valve, Part No. MU3226 for the AU400, AU640, AU2700, and AU5400 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples. AU400, Item Code: 5427200 5427400 5427600 N1254000 N1254200 N1254400 N1254600 N1255000 n1255200 N1257400 N2571700 N2571800 N3658500 N3658700 N3658800 N3659000 N3659400 N3912300 N9020723 N9020724 AU400 OPA, Item Code: 5427300 5427900 N1257700 AU640, Item Code: 5900100 5900400 5900600 N1255700 N1255900 N1256100 N1256300 N1256700 N2572800 N3660900 N3661200 N3661300 N3661500 N3661700 N3661900 AU640 OPA, Item Code: 590220 5902400 A92928 A92929 AU2700, Item Code: 5996300 5996500 5998100 N1465100 N1465300 N1465500 N1465600 N1465900 N1466100 N1815200 N1815600 N1815700 N1816200 N1816300 N3155800 N3155900 N3156000 N3156100 N3156200 N3156300 N3156400 N3156500 N3156600 N3156800 N3157000 N3663100 N3663300 N3663500 N3663600 N3663800 N3663900 N3664100 N3664300 N3664500 N3664700 N3664900 N3878600 AU2700 OPA, Item Code: 5996100 N3156700 N9025844 AU5400 OPA, Item Code: 6196400 6196500 6196700 N1257900 N1258000 N3666000 N3877100 N3877200 N3877300 N3877600 N3877700 Class II The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected. Beckman Coulter Inc.
Devices ISE REF Valve, Part No. MU7638 for the AU480, AU680, and AU5800 Chemistry Analyzer. Automated chemistry analyzers that measures analytes in samples. AU480, Item Code: N3151200 N3151300 N3151400 N3151500 N3151600 N3151700 N3151800 N3151900 N3659600 N3659700 N3659900 N3660000 N3660200 N3660400 N3660600 N3660800 N3912500 AU480 OPA, Item Code: B11803 N3152300 N3152400 N3152500 N3152600 N3912600 AU680, Item Code: B12184 B12185 B12187 B12188 N3147100 N3147200 N3147300 N3147400 N3147500 N3148100 N3149800 N3153300 N3153700 N3153800 N3154000 N3658100 N3662100 N3662200 N3662400 N3662900 N3663000 N3910100 N3910400 N3910500 N3910800 N3910900 N3911200 N3911300 N3911900 AU680 OPA: B11474 N3148300 N3148600 N3148700 N3150500 N3912700 AU5800 OPA, Item Code: A94927 A94928 A94929 A94930 N9028030 Class II The recall was initiated because Beckman Coulter has confirmed that some AU Clinical Chemistry Analyzer ISE units can experience premature ISE REF (Reference) valve failure. Premature valve failure can be detected by the presence of air bubbles in the ISE REF solution tubing on the ISE unit. If air bubbles are present, accuracy of the ISE test results may be affected. Beckman Coulter Inc.
Devices Emit 2000 Phenobarbital Assay and Syva Emit 2000 Phenobarbital Assay Lots: E5-E7, F1-F5, 1290, 1300, 1313, 1330, 1338, 1367, 1371, and 1380. Class II Imprecision with certain lots Siemens Healthcare Diagnostics, Inc.
Drugs Prolia (denosumab) Injection, 60 mg/mL, 1 x 60 mg Single Use Prefilled Syringe per carton, Rx only, Manufactured by: Amgen Manufacturing Ltd., a subsidiary of Amgen Inc., Thousand Oaks, CA 91320-1799,NDC 55513-710-01, UPC 3 55513 71001 5. Lot #: 1037592, Exp 07/15 Class II Presence of Particulate Matter: Visible cellulose fibers were observed in a small number of prefilled syringes during a routine quality examination. Amgen, Inc.
Devices Calcium Arsenazo, CALA-0250, For the Quantitative Determination of Total Calcium in Human Serum. The kit label shows CALCIUM ARSENAZO, CALA-0250, R: 12x20 mL. The vial's label shows CALCIUM ARSENAZO, CALA-5220, 20 mL, . CALCIUM ARSENAZO is intended use for the quantitative in vitro diagnostic determination of total calcium in human serum and plasma on ELITech Clinical Systems Selectra Pro Series Analyzers. Calcium measurements are used in the diagnosis and treatment of parathyroid disease, a variety of bone diseases, chronic renal disease and tetany (intermittent muscular contractions or spasms). It is not intended for use in Point of Care setting. Lot numbers distributed in the US: Lot 11-2614, Expiration 07/2013. Lot 12-1002; Expiration 03/2014. Lot 12-2220, Expiration 08/2014. Lot numbers distributed in Sweden: 11-2129, 12-2616, 11-2769, 12-2975, 10-3036, 10-0454, 10-1874, 11-0176, 11-1248, 11-1690, 12-0140, 12-0938, 12-1383, 13-0004, and 13-0408 Class II Calcium Arsenazo Reagent, reference CALA-0250, is recalled due to complaint of plasma specimens report high results than serum. SEPPIM SAS
Devices Fresenius Liberty® Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis. All serial numbers Class II Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis Fresenius Medical Care Holdings, Inc.
Devices Portex® Spinal Tray with Drugs 22g Whitacre/25g Whitacre; 15248C-22/25 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. Lot Number: 2440516 Class II Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. Smiths Medical ASD, Inc.
Devices Portex® Spinal Tray with Drugs 22g/25g Quincke; 15249-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. Lot Number: 2445601 Class II Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. Smiths Medical ASD, Inc.
Devices Portex® Spinal Tray with Drugs 25g Whitacre; 15545C-21 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. Lot Number: 2440517 Class II Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. Smiths Medical ASD, Inc.
Devices Portex® Regional Anesthesia Tray with Drugs; 15548-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. Lot Number: 2450807 Class II Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. Smiths Medical ASD, Inc.
Devices Portex® Spinal Tray with Drugs 25g Whitacre; 15597-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. Lot: 2445604, 2440523, 2445605, 2445606, 2450812 Class II Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. Smiths Medical ASD, Inc.
Devices Portex® Spinal Tray with Drugs 25g Whitacre; 15597C-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. Lot: 2426443, 2431124, 2440524, 2450808 Class II Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. Smiths Medical ASD, Inc.
Devices Portex® Saddleblock Tray with Drugs 26g Quincke, 4745-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. Lot: 2445619 Class II Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. Smiths Medical ASD, Inc.
Devices Portex® Saddleblock Tray with Drugs 22g Quincke (Without Introducer); 4792-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. Lot: 2450793 Class II Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. Smiths Medical ASD, Inc.
Devices Portex® Saddleblock Tray with Drugs  25g Quincke; 4795-20 The Regional Anesthesia family of products is comprised of sterile (unless otherwise indicated in the product scope), single-use devices designed to perform epidural, spinal, combined epidural/spinal, nerve block, lumbar puncture and regional anesthesia procedures. The spinal products are comprised of spinal needles, introducer needles and accessories required to perform a spinal procedure. Lot: 2455104 Class II Visual particulate in the glass ampules of 5% Lidocaine HCL and 7.5% Dextrose Injection, USP, 2 mL Ampoule, NDC # 0409-4712-01, Hospira Lot Number 23-227-DK. These ampules are included in certain Portex Spinal Anaesthesia Trays. Smiths Medical ASD, Inc.
Devices Surgicutt fully automated incision making device for bleeding time determination. ITC 8 Olsen Avenue, Edison, NJ 08820. 732.548.5700. www.itcmed.com. A subsidiary of Thoratec Corporation. The device is a spring loaded cam driven device that provides standardized incisions of 5 mm length and 1 mm depth. This fully automated instrument is used along with blotting paper for bleeding time determinations. Product Code: SUB50I; Lot No. AK301M. Lot Expiration Date 8/31/2017 Class II ITC has determined that the blade in their Surgicutt with Blotting Paper (Product Code: SUB50I; Lot: AK301M) devices may be loose. ITC-Nexus Dx
Devices Baylis Medical TorFlex Transseptal Guiding Sheath, Rx Only, non-pyrogenic, sterile. Product Usage: The TorFlex Transseptal Guiding Sheath kit (K102948) is a single use device consisting of three components: a sheath, a dilator, and a J-tipped guidewire. The kit is designed for safe and easy catheterization and angiography of specific heart chambers and locations. Part No. TF8-32-63-135, Lot TFFB070912; Part No.TF8-32-63-37, Lot TFFA310812; Part.  ...
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Class I The TorFlex Transseptal Guiding Sheath Kits are being recalled due to the possibility that the sheath could remove particulate of less than 5 mm from the dilator. The particulate could potentially migrate into a patients bloodstream. Baylis Medical Corp *
Food Jim Dandy® Iron Fortified Quick Grits, 1lb paper box, Labeled in part "INGREDIENTS: IRON, WHITE CORN GRITS, NIACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 11501 5***3067 511 Best If Used By 8-NOV-14***" 3067 211 Best If Used By 8-NOV-14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food Jim Dandy® Enriched Quick Grits, 1lb paper box, Labeled in part INGREDIENTS: WHITE CORN GRITS***NACIN, THIAMIN, MONONITRATE, RIBOFLAVIN, FOLIC ACID. DISTRIBUTED BY: MARTHA WHITE FOODS, INC., P. O. BOX 751030 MEMPHIS, TN 38175***0 13300 12107 8***3143 511 BEST IF USED BY: 23-JAN-14*** 3143 511 BEST IF USED BY: 23-JAN-14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food Martha White® SELF-RISING Corn Meal Bolted White Enriched Hot Rize Net Wt 5 lb (2.26 kg) Paper bag, Mfg Code 3127 511 BEST IF USED BY: 7-Jan-14, Product labeled in part, INGREDIENTS: ENRICHED BOLTED WHITE CORN MEAL***BAKING POWDER***SALT***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***013300 18701 2 3127 511 BEST IF USED BY: 7-Jan-14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food Gladiola® White Cornbread Mix, Net Wt 6 oz (170g) Laminated Pouch Mfg Code 3101 501 BEST IF USED BY: 11 APR 14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, AND ENRICHED BLEACHED FLOUR***PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***MAY CONTAIN***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 54133 3 3101 501 BEST IF USED BY: 11 APR 14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food Martha White® Buttermilk Cornbread & Muffin Mix NET WT 6 OZ (170g) Laminated Pouch Mfg Code 3105 501 BEST IF USED BY: 15 APR 14 Product labeled in part INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, WHEAT FLOUR*** PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***MAY CONTAIN***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 51701 7 3105 501 BEST IF USED BY: 15 APR 14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food Martha White® COTTON COUNTRY CORNBREAD BUTTERMILK CORNBREAD MIX NET WT 6 OZ (170g) Laminated Pouch Mfg Code 3106 501 BEST IF USED BY: 16 APR 14 & Mfg Code 3107 501 BEST IF USED BY: 17 APR 14 Product labeled in part, â¬SINGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, AND ENRICHED BLEACHED FLOUR***PARTIALLY DEHYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER***MAY CONTAIN***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 53101 3â¬쳌 3106 501 BEST IF USED BY: 16 APR 14 & 3107 501 BEST IF USED BY: 17 APR 14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food Martha White® SELF-RISING BUTTERMILK CORN MEAL MIX White-Enriched Hot Rize NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3151 511 BEST IF USED BY: 31 JAN 14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***BUTTERMILK; SALT.***CONTAINS: MILK AND WHEAT INGREDIENTS***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 18301 4 3151 511 BEST IF USED BY: 31 JAN 14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food WHITE LILY® ENRICHED WHITE Cornmeal MIX SELF-RISING NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3135 511 BEST IF USED BY: 15-JAN-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS: WHEAT INGREDIENTS MAY CONTAIN MILK INGREDIENTS***DISTRIBUTED BY: THE WHITE LILY FOODS COMPANY 4740 BURBANK ROAD, MEMPHIS, TN 38118***0 13300 02281 7 3135 511 BEST IF USED BY: 15-JAN-14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food Martha White Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 5 LB (2.26kg) Paper Bag Mfg Code 3152 511 BEST IF USED BY: 1-Feb-14; White Lily Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 32 OZ (2 lb) 907g Paper Bag Mfg Code 3157 511 BEST IF USED BY: 6-Feb-14; Martha White Buttermilk Cornmeal Self-Rising, White, Enriched NET WT 32 OZ (2 lb) 907g Paper Bag Mfg Code 3191 511 BEST IF USED BY: 10-Mar-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS: MILK AND WHEAT INGREDIENTS***DISTRIBUTED BY: MARTHA WHITE FOODS INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 18601 5 3152 511 BEST IF USED BY: 1-Feb-14; 3157 511 BEST IF USED BY: 6-Feb-14; 3191 511 BEST IF USED BY: 10-Mar-14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food Martha White Corn Meal Plain, White, Enriched NET WT 32 OZ (2 LB) 907g Paper Bag Mfg Code 3193 511 BEST IF USED BY: 12-Mar-14 Product labeled in part, INGREDIENTS: WHITE CORN MEAL, NIACIN, IRON, THIAMIN MONONITRATE, RIBOFLAVIN, FOLIC ACID*** MAY CONTAIN MILK AND WHEAT INGREDIENTS ***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 13501 3 3193 511 BEST IF USED BY: 12-Mar-14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food White Lily Corn Meal Self-Rising, White, Enriched NET WT 5 lb (2.26kg) Paper Bag Mfg Code 3193 511 BEST IF USED BY: 12-Mar-14 Product labeled in part, INGREDIENTS: ENRICHED WHITE CORN MEAL, WHEAT FLOUR AND DEGERMINATED WHITE CORN MEAL***BAKING POWDER***SALT***CONTAINS: WHEAT INGREDIENTS MAY CONTAIN MILK INGREDIENTS***DISTRIBUTED BY: THE WHITE LILY FOODS COMPANY 4740 BURBANK ROAD, MEMPHIS, TN 38118***0 32500 02381 4 3193 511 BEST IF USED BY: 12-Mar-14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Food Martha White Cotton Country Cornbread, NET WT 6 OZ (170g) Paper Bag Mfg Code 3107 501 BEST IF USED BY: 17-Apr-14 Product labeled in part, INGREDIENTS: ENRICHED DEGERMINATED WHITE CORN MEAL, ENRICHED BLEACHED FLOUR***PARTIALLY HYDROGENATED SOYBEAN OIL, DEXTROSE, BAKING POWDER*** BUTTERMILK***SALT, SUGAR, SOY LECITHIN, GUAR GUM, NONFAT MILK, MALTODEXTRIN, CELLULOSE GUM, CORN STARCH.*** CONTAINS MILK, SOYBEAN AND WHEAT INGREDIENTS, MAY CONTAIN ALMOND, BRAZIL NUT, CASHEW, EGG, HAZELNUT, MACADAMIA NUT, PECAN, PINE NUT, PISTACHIO NUT AND WALNUT INGREDIENTS. ***DISTRIBUTED BY: MARTHA WHITE FOODS, INC. P.O. BOX 751030, MEMPHIS, TN 38175***0 13300 53101 3 3107 501 BEST IF USED BY: 17-Apr-14 Class II The states of Alabama and North Carolina through independent testing notified JM Smucker that aflatoxin levels exceeded FDA specification (<20 ppb). Levels tested ranged from 30 ppb to 207 ppb. J M Smucker Co
Devices UniCel DxH 800 and DxH 600 Coulter Cellular Analysis Systems The UniCel DxH 800/DxH 600 analyzers are quantitative, multiparameter, automated hematology analyzers for in vitro diagnostic use in screening patient populations found in clinical laboratories. The DxH 800 is available as an analyzer for use on a tabletop or with a floor stand. The DxH 600 is available as an analyzer for use on a tabletop only. Part Numbers: 629029 for DxH 800 and B23858 for DxH 600. Serial Numbers: AS49437 AV11229 AV23436 AV28032 AT05062 AU32435 AT27373 AT09132 AV06132 AV06143 AT21266 AT21268 AT23307 AS46410 AS46411 AU48003 AV05097 AT27346 AT40554 AU23277 AV05082 AV05092 AV11205 AT06076 AT09112 AT09114 AT16214 AT18235 AV11214 AV11217 AN30069 AS07008 AT09116 AS40361 AU05048 AU05054 AT48658  ...
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Class II Beckman Coulter is initiating a recall for UniCel DxH 800 Coulter Cellular Analysis System (PN 629029) and UniCel DxH 600 Coulter Cellular Analysis System (PN B23858) because the company's internal investigation indicates that specific lots of check valves used in several locations within the DxH 800 and DxH 600 systems may fail. A failure may result in an air or liquid leak at the VCS Waste Chamber or Probe Waste Chamber. Beckman Coulter Inc.
Food Angel Food Cake; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cake 0 lb. 12 oz. (340 g) Black or White Base with Clear Lid UPC code 211301010510 with sell by dates of 9/1/13 to 10/1/13. Class I Incorrect labels were provided to stores that omitted milk and soy. Safeway Inc
Food Holiday Decorated Angel Food Cake; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Holiday Decorated Angel Food Cake  1 lb. 14 oz. (850 g); Black or White Base with Clear Lid; frosted/decorated sell by dates of 9/1/13 to 10/1/13. Class I Incorrect labels were provided to stores that omitted milk and soy. Safeway Inc
Food Angel Food Cups 4 Count; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cups 4 Count  0 lb. 3 oz. (85g); Individual cake cups sold in package of 4 items. sell by dates of 9/1/13 to 10/1/13. Class II Incorrect labels were provided to stores that omitted milk and soy. Safeway Inc
Food Cake Angel Food Loaf: 1) Cake Angel Food Loaf; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Cake Angel Food Loaf 0 lb. 4 oz. (113 g) Cake Angel Food Loaf Individual loaf sold in package of 1 item 2) Cake Angel Food Loaf - 2 count labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cake Loaf 2 Count 4 oz., and 10 oz. (283 g); Angel Food Cake Loaf 2 Count Individual loaf sold in package of 2 items. sell by dates of 9/1/13 to 10/1/13. Class I Incorrect labels were provided to stores that omitted milk and soy. Safeway Inc
Food Angel Food Cake Fruit Topped; labeled for retail sale in the following stores: Safeway, Carrs, Dominicks, Genuardis, Pak N Save, Pavilions, Randalls, Tom Thumb and Vons. Angel Food Cake Fruit Topped  3 lb. 12 oz. (1701 g); Angel Food Cake Fruit Topped  Black or White Base with Clear Lid; fruit topping. sell by dates of 9/1/13 to 10/1/13. Class II Incorrect labels were provided to stores that omitted soy flour in ingredient statement. Soy oil and soy lecithin are listed in the ingredient statement. Safeway Inc
Drugs Amlodipine Besylate Tablets, USP, 2.5 mg, packaged in a) 90-count bottles (NDC 0378-5208-77) and b) 500-count bottles (NDC 0378-5208-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Lot #: a) 3037907, 3040106; b) 3037907, 3040106, 3044357 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Amlodipine Besylate and Benazepril HCl Capsules, 2.5 mg/10 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-6895-01 Lot #: 2003156, 2003157, 2003155, 3043491 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Lamotrigine Tablets, USP, 200 mg, packaged in a) 60-count bottles (NDC 0378-4254-91) and b) 500-count bottles (NDC 0378-4254-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Lot #: a) 2003194, 2003195; b) 2003193 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Ciprofloxacin Tablets, USP, 250 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7097-01 Lot #: 3032075, 3032076 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Amlodipine Besylate Tablets, USP, 5 mg, packaged in a) 90-count bottles (NDC 0378-5209-77) and b) 500-count bottles (NDC 0378-5209-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Lot s: a) 3036490, 3036491, 3036492, 3039874; b) 3036493, 3036494, 3039872, 3039873, 3041476, 3041477, 3044555, 3044683 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/10 mg, packaged in a) 100-count bottles (NDC 0378-6896-01) and b) 500-count bottles (NDC 0378-6896-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Lot #: a) 2003159, 2003160, 2003161, 3043492; b) 2003158, 2003159, 3043492 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/20 mg, packaged in a) 100-count bottles (NDC 0378-6897-01) and b) 500-count bottles (NDC 0378-6897-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Lot #: a) 2003169, 2003170, 2003171, 2003172, 2003173, 3043493; b) 2003168, 2003169, 3043493 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Amlodipine Besylate and Benazepril HCl Capsules, 5 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6899-01 Lot #: 2003184, 2003185, 2003186, 3043495 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Amlodipine Besylate and Benazepril HCl Capsules, 10mg/20mg, in 100 count bottles (NDC# 0378-6898-01) and 500 count bottles (NDC# 0378-6898-05) labeled in part ***Mylan Pharmaceuticals Inc. Morgantown, WV 26505 U.S.A.*** Lot #: a) 2003177, 2003178, 2003179, 2003180, 3043496; b) 2003176, 2003177, 3043496 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Amlodipine Besylate and Benazepril HCl Capsules, 10 mg/40 mg, 100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-6900-01 Lot #: 2003188, 2003189, 2003190, 2003191, 3043498 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Ciprofloxacin Tablets, USP, 500 mg,100-count bottles, Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A, NDC 0378-7098-01 Lot #: 2002732, 2002733, 2002734, 2002735, 2002736, 2002737, 2002738, 2002739, 2002740, 2002741, 2002742, 2002743, 2002744, 2002745, 3030000, 3030001, 3030002, 3030003, 3030004, 3030005, 3030006, 3030016, 3030017, 3030018, 3030216, 3030217, 3030218, 3030219, 3030220, 3030221, 3030222, 3030223, 3030224, 3030225, 3030226, 3030227, 3030228, 3030229, 3030238, 3030351, 3030352, 3030354, 3030355, 3030356, 3030357, 3030358, 3031790, 3031792,  ...
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Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Drugs Amlodipine Besylate Tablets, USP 10 mg, packaged in a) 90-count bottles (NDC 0378-5210-77) and b) 500-count bottles (NDC 0378-5210-05), Rx only, Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A. Lot #: a) 3038984, 3038985, 3038986, 3041484, 3041485; b) 3036828, 3036829, 3036830, 3036831, 3036832, 3038987, 3038988, 3038989, 3038990, 3041480, 3041481, 3041482, 3041483, 3044522, 3044525 Class II CGMP Deviations: Pharmaceuticals were produced and distributed with active ingredients not manufactured according to Good Manufacturing Practices. Mylan Pharmaceuticals Inc.
Devices HAMILTON-C2 Ventilator: Manufactured by Hamilton Medical AG CH-7402 Bonaduz, Switzerland; Imported and distributed by Hamilton Medical, Inc. Reno, NV 89502 The HAMILTON C2 ventilator is intended to provide positive pressure ventilatory support to adults, pediatrics, infants and neonates depending on its configuration. Intended areas of use: In the intensive care ward or in the recovery room; During transfer of ventilated patients within the hospital. Hamilton-C2; Serial numbers from 1000-7100. Class II Manufacturer defined limits for improperly functioning loudspeakers of the HAMILTON C2 alarm system were exceeded. Hamilton Medical, Inc.
Devices Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3 LOTS: 1057760, 1057919 and 1059222 Class III InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body. Helix Medical LLC
Devices OmniPod Insulin Management System Starter Kit; Model Reference Number: SKT-UST400 (Starter Kit) Product Usage: The Starter Kit (SKT-UST400) is provided to users as an introduction to the OmniPod Insulin Management System prior to initiating care. It includes the Personal Diabetes Manager (PDM) with two AAA alkaline batteries, a USB cable, a Users Guide, a Soft Carrying Case, a Troubleshooting guide, a Warranty Registration Card, and two Alcohol Pads. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly. Lot Numbers: L13483, L13485, L13478, & L13481 Class II Alcohol Prep Pads contained within the kit are not properly labeled. Insulet Corporation
Devices OmniPod Insulin Management Product Demonstration Kit; Model Reference Number: (PDK-ZXP490) Product Usage: The Demonstration Kit (PDK-ZXP490) is an alternate kit provided to potential patients by healthcare professionals for patients to experience what wearing a Pod may feel like prior to purchase. Each Demonstration Kit includes a UST400 brochure, one Alcohol Pad, and a Pod. The OmniPod Insulin Management System is intended for subcutaneous delivery of insulin at set and variable rates for the management of diabetes mellitus in persons requiring insulin and for the quantitative measurement of glucose in fresh whole capillary blood (in vitro) from the finger. The glucose measurements should not be used for the diagnosis of or screening for diabetes. The PDM glucose meter is intended for single-patient use and should not be shared. Abbott FreeStyle test strips are used with the built-in FreeStyle meter for the quantitative measurement of blood glucose in fresh whole capillary blood from the finger, upper arm and palm. Abbott Freestyle Control Solutions are used to verify that the meter and test-strips are working together properly and that the test is performed correctly. Lot Numbers: L13470 Class II Alcohol Prep Pads contained within the kit are not properly labeled. Insulet Corporation
Food Giant Eagle Candy Place Candy Corn Mix in a clear plastic container, net wt. 13 oz, Distributed by Giant Eagle Inc. UPC#3003406974 Sell By Date 040814 Class I Undeclared milk, egg, peanut, and soy allergens in Giant Eagle Candy Place Candy Corn Mix Giant Eagle, Inc.
Food Pectinase 3,500 ENDO-PG/G, powder, enzyme, 100 gm. Product 70A Lot ALI13157-09; re-evaluation date 12/6/2014. **sample only - not tested On 10/22/2013 American Laboratories provided CFSAN a customer distribution list for the Chloramphenicol Contamination. This spreadsheet listed the base concentrate levels. The data was highlighted: Green, Yellow, Red and Orange.The spreadsheet Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Xylanase 150,000XU, powder, enzyme, 100 gm. Product 13A Lot ALI13157-11; re-evaluation date 12/6/2014 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Xylanase 10,000XU/g, powder, enzyme, 100 gm. Product 45A Lot ALI13206-05; re-evaluation date 1/25/2015 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Xylanase 70,000XU/g, powder, enzyme, 100 gm. Product 71A Lot ALI13206-06; re-evaluation date 1/25/2015 and Lot # ALI13008-13; re-evaluation date 7/8/2014 **sample only - not tested Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food NUT 14-500, powder, plant enzyme blend, packaged in 15 kg and 23 kg double poly bags inside fiber box. Product 98A 15 KGS: Lot ALI13212-04; re-evaluation date 1/31/2015 and 23 KGS: Lot # ALI13036-01; re-evaluation date 8/5/2104. **Lot ALI13212-04 mathmatical analysis tested "probably < 0.3 ppb in final product" **Lot ALI13036-01 mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food PC Blend 14, powder, enzyme blend, packaged in 9 kg and 25 kg double poly bags inside fiber box. Product 62A 9 KGS: Lot ALI13249-03; re-evaluation date 3/6/2015 and 25 KGS: Lot # ALI13024-02; re-evaluation date 7/24/2014. **Lots ALI13249-03 and ALI13024-02 mathmatical analysis tested "probably < 0.3 ppb in final product" **Lot ALI13036-01 mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food Ultra Blend 102, powder, enzyme blend, packaged in 25 kg double poly bags inside fiber box. Product 73B, SI Item # 10678. Lot # ALI13053-05; re-evaluation date 8/22/2104 **Lot ALI13053-05 mathmatical analysis tested "VERY probable NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food EB 110311-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 73C Lot # ALI13200-09, re-evaluation date 1/19/2015; Lot # ALI13140-03, re-evaluation date 11/20/2014; Lot # ALI13071-01, re-evaluation date 9/12/2014 and Lot # ALI13008-01; re-evaluation date 7/8/2014. **Lot ALI13200-09 mathmatical analysis tested "probably < 0.3 ppb in final product" **the other three lots mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food EB 020812-01, powder, enzyme blend, packaged in 5 kg double poly bags inside fiber box. Product 77C Lot # ALI13200-08, re-evaluation date 1/19/2015; Lot # ALI13140-02, re-evaluation date 11/20/2014; Lot # ALI13071-02, re-evaluation date 9/12/2014 and Lot # ALI13008-02; re-evaluation date 7/8/2014. **Lot ALI13200-08 mathmatical analysis tested "probably < 0.3 ppb in final product" **the other three lots mathmatical analysis tested "probably NOT < 0.3 ppb in final product" Class II The products may be contaminated with Chloramphenicol. American Laboratories Inc
Food VIT-RA-TOX Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 48. National Distributors: V.E. Irons, Inc, N. Kansas City, MO. Springreen Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 88. National Distributors: Springreen Products, Inc, N. Kansas City, MO. Sonne's Whole Beet Plant Juice, dietary supplement, dry, 400 mg tablet, packaged in 150 tablets glass, amber bottles. No. 18. National Distributors: Sonne's Organic Foods, Inc., N. Kansas City, MO All three labels have the same lot code: 06-11-15-2 Class II The firm reports a customer found a foreign object in the product. Vitalab Co Inc
Drugs Irinotecan Hydrochloride Injection, 40 mg/2 mL (20 mg/mL), 1 x 2 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9702-01. Lot #: AC0020, Exp 03/14; AC0023, AC0025, Exp 08/14 Class II Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim. West-Ward Pharmaceutical Corp.
Drugs Irinotecan Hydrochloride Injection, 100 mg/5 mL (20 mg/mL), 1 x 5 mL Single Dose Vial per carton, Rx only, Manufactured by: Thymoorgan Pharmazie GmbH, Schiffgraben 23, 38690 Vienenburg, Germany; Distributed by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA, NDC 0143-9701-01. Lot #: AC0026, AC0027, Exp 10/14 Class II Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim. West-Ward Pharmaceutical Corp.
Devices Dekompressor Percutaneous Discectomy Probe. The Dekompressor is a single use disposable discectomy probe that passes through and works in conjunction with an introducer cannula to remove intervertebral disc nucleus pulposus material. Part Number(s) 0407-251-000, 0407-260-000, 0407-265-000, 0407-266-000, 0407-280-000, and 0407-281-000. Class II Stryker has identified a potential for the auger and/or cannula to fracture when the Dekompressor is used contrary to the warnings in the Instructions For Use (IFU). Specifically, manually bending the cannula can weaken the device and may result in a fracture of the auger and/or cannula. This could result in the need for additional medical intervention to remove the broken piece, pain or loss of mobility. There have been no deaths or serious adverse events. Stryker Instruments Div. of Stryker Corporation
Devices Individual units labeled in part: REF: 4630022; for S(a)line resectoscopes; Vaporization electrode, sterite; 4mm telescope 30 25 / 12: only for continuous irrigation sheath 24,5 Fr.; LOT 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF; Cartons of 3 units labeled in part: REF 46300223; Vaporization electrode, sterile; 4mm telescope 30/25/12; only for continuous irrigation sheath 24,5 Fr.; Lot 426111; 2011/06; 2016/06; STERILE; RICHARD WOLF S(a)line Resectoscopes are used for endoscopically controlled removal (ablation) of tissue using 0.9% NaCl solution (saline) as the irrigation medium. It can also be used for monopolar resection if necessary. *** Individual Units *** Product Code: 4630022; Lot: 426111; Expiration Date: 2016/06; *** Cartons *** Product Code: 4630023; Lot: 426111; Expiration Date: 2016/06; Class II Richard Wolf Medical Instrument Corporation recieved a complaint stating that a 4630024 vaporization electrode was packaged in a 4630022 pouch. Richard Wolf Medical Instruments Corp.
Drugs Ropinirole, extended-release tablets, 2 mg, 90 count bottle, Rx only, Manufactured in India by Sandoz Private Ltd, for Sandoz Inc, Princeton, NJ 08540, NDC 0781-5780-92 Lot DJ2744, Exp 12/2014 Class II Cross contamination with other products: Sandoz is recalling certain lots of Ropinirole Extended Release Tablets 2 mg due to the potential presence of carryover coming from the previously manufactured product, mycophenolate mofetil. Sandoz, Inc
Devices Aquatec Ocean VIP, Aquatec Ocean Dual-VIP, Aquatec Ocean E-VIP mobile shower and toilet commode with tilting function. Mobile shower and toilet commode with tilting function The following model and serial numbers were affected by this recall: Aquatec Ocean VIP Model number: 1470793 Serial numbers: 14541797; 14541800; 14541803; 14541804; 14541805; 14541806; 14541807; 14541808; 14541809; 14541810; 14541812; 14541820; 14541821; 14541822; 14541823; 14541825; 14541836; 14541837; 14541838; 14541839; 14541841; 14541842; 14541886; 14541918; 14541931; 14541937; 14541940; 14541941; 14541942; 14541944; 14541967;  ...
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Class II The snap-on fixtures of the backrest cushion on the Mobile Shower and Toilet Commode Aquatec Ocean VIP and Ocean Dual VIP do not withstand a required pull out force of 500 N, when the product is used in a reclined position and or tilted position. This may result in the snap-on fixture coming unlatched. Invacare Corporation
Devices S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less. Serial Numbers: 48E00235,48E00339,48E00342,48E01753,48E02767,48E02753,48E02745,48E02746,48E02748,48E02416,48E01033,480E1038,48E01040,48E01041,48E01043,48E01044,48E01051,48E02631,48E01183,48E02758,48E02764,48E01832,48E01834,48E02278,48E02722,48E02732,48E02326,48E02797,48E02793,48E02791,48E02781,48E02785,48E02786,48E02783,48E02772,48E02802,48E02778,48E02784,48E02788,48E02789,48E02779,48E02792,48E02790,48E02771,48E02773,48E02776,48E02799,48E02801 Class II Sorin Group is recalling certain models of S5 Perfusion Systems due to malfunction of cardioplegia control. Sorin Group Deutschland GmbH
Devices Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids, or in various kit configurations with one band per kit. Product Usage: Intended for use in surgical treatment of morbid obesity The following product code and lot numbers were affected by this recall: Product Codes: RLZB22 Lot Numbers: ZJKBK6, ZJLBBR, ZJLBBT, ZJLBBV, ZJMBB5, ZJMBCG, ZJMBCH, ZJMBCJ, ZJMBCK, ZJMBCL, ZJMBJC, ZJMBJD, ZJMBJF, ZJPBD1, ZJPBD2, ZJPBFT, ZJPBFV, ZKBBCC, ZKBBCD, ZKBBCF, ZKBBCG, ZKBBGC, ZKBBGD, ZKBBGJ, ZKBBJN, ZKBBNV, ZKBBNW, ZKBBNY, ZKCBBK, ZKCBDD, ZKCBJJ, ZKMBK4, ZKMBKP, ZKNBBB,  ...
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Class II During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. Ethicon Endo-Surgery Inc
Devices Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity The following product code and lot numbers were affected by this recall: Product Codes: 2200-X Lot Numbers: ZLGBC5, ZLNBCW, ZLNBJC, ZLPBB9, ZMBBBB, ZMCBBC, ZMGBCJ, ZMHBBT, ZMHBCV, ZMLBD0, ZMMBCD, ZMPBBC, ZNCBC6, ZNGBB3, and ZNGBBF. Class II During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. Ethicon Endo-Surgery Inc
Devices Adjustable Gastric Band, packaged alone in transparent PETG inner and outer blisters with Tyvek lids. Product Usage: Intended for use in surgical treatment of morbid obesity The following product code and lot numbers were affected by this recall: Product Codes: BD2XV Lot Numbers: ZJMBB4, ZJMBN9, ZJNBBV, ZKDBM6, ZKDBM7, ZKFBDC, ZKGBDY, ZKHBBJ, ZKHBCR, ZKHBFG, ZKNBCK, ZKNBHC, ZLBBFK, ZLDBB8, ZLFBBC, ZLFBGG, ZLGBFV, ZLGBG5 , ZLJBCL, ZLMBBD, ZLMBYF, ZLNBCH, ZMBBGJ, ZMCBDL, ZMFBCT, ZMGBDF, ZMKBCG, ZNBBBB, and ZNCBBB. Class II During aging studies, the firm determined that the gastric belts were unable to pass the test requirements established for Force to Lock. Ethicon Endo-Surgery Inc
Devices pH 7.0 Buffer Solution Pint and Quart Bottles, Part Number 02.0030 for Pints and 02.0031 for Quarts. Packaged in Plastic Bottles. Can be sold individually or in cartons with 6 bottles per box (for quart bottles only). Used in the hemodialysis setting to calibrate pH meters. ML-P7-1110 Exp NOV 11 2013, ML-P7-1118 Exp JAN 12 2014, ML-P7-1122 Exp FEB 23 2014, ML-P7-1128 Exp APR 17 2014, ML-P7-1137 Exp JUN 17 2014, ML-P7-1138 Exp JUL 4 2014, ML-P7-1148 Exp SEP 14 2014, ML-P7-1149 Exp SEP 19 2014, ML-P7-1158 Exp DEC 7 2014, ML-P7-1164 Exp JAN 19 2015 Class II Mesa Laboratories, Inc. is recalling certain lots of pH 7.0 Buffer Solution due to mold growth. Mesa Laboratories, Inc.
Devices The EkoSonic Endovascular System employs high frequency (2-2.5 MHz), low power (0.585 watt average power per transducer) ultrasound to facilitate the delivery of physician-specified fluids in the peripheral vasculature and to deliver solutions into the pulmonary arteries. The EkoSonic Endovascular System is intended for the controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature and the infusion of solutions into the pulmonary arteries. The reusable EKOS EkoSonic Control Unit provides power to the system and the user interface for operator control. A reusable, non sterile Connector Interface Cable connects the EKOS EkoSonic Control Unit to the EkoSonic Endovascular Device. PT3B-783. PT3B represents the model number. Adding 783 creates the serial number. Class II The EkoSonic Control Unit is recalled because it had the incorrect power entry module installed. It is missing an AC filter to reduce the noise and electrical interference. EKOS Corporation
Food Custom made gift boxes containing: HONEY ROASTED PEANUTS, Net Wt. 11 oz. (311G), Dist.By: Dutch Valley Food Distributors, Inc. Myerstown, PA 10787, UPC 8 77245 00143 3 None Class I Honey Roasted Peanuts, packaged in custom gift boxes, contained milk and wheat which were not declared on the label. yoders country market
Devices Patient Cart used in conjunction with the da Vinci S surgical and SI System. Intuitive Surgical 1266 Kifer Road Sunnyvale, CA 94086 The Patient Side Cart (PSC) is a robotic platform used for da Vinci Surgery. It is the operative component for both da Vinci systems and its primary function is to support he instrument arms and camera arm. It uses remote center technology. The remote center is a fixed point in space around which the Patient Cart arms move. Remote center technology enables the system to maneuver instruments and endoscopes in the surgical site while exerting minimal force on the patient body wall. The Patient Cart works in the sterile field, assisting the Surgeon Console operator by exchanging instruments and endoscopes, and by performing other patient-side activities. To help ensure patient safety, the action of the Patient Cart operator take precedence over actions of the Surgeon Console operator. Model IS2000 and IS 3000 Class II Increased number of complaints regarding fluid entering the patient card base of the da Vinci S and SI systems. Intuitive Surgical, Inc.
Devices Resolute Integrity Zotarolimus-eluting Coronary Stent: Stent ID 3.0 mm; Stent length 34 mm; Rx, Sterile. Mfg in Medtronic Ireland, Galaway, Ireland. Distributed by: Medtronic Inc. Minneapolis, MN. Indicated for improving coronary luminal diameters in patients. Model: RSINT30034UX; Customer Facing Number: RSIST30034UX. Expiration date: 25 May 2014. Class II A small number of units in lot number 0006573585 of the Resolute Integrity Zotarolimus-Eluting Coronary Sten System may contain a compliance chart incorrectly referencing a 2.25 mm diameter instead of the correct 3.0mm. Medtronic Vascular, Inc.
Devices GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 5, LEFT, QTY: (1), REF 71420168. Product Usage: orthopaedic Batch No. 13GM11272 Class II Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. Smith & Nephew Inc
Devices GENESIS(R) II, NON-POROUS TIBIAL BASE, SIZE 6, RIGHT, QTY: (1), REF 71420188. Product Usage: orthopaedic Batch No. 13GM09505 Class II Swapped product. Non-porous tibial base size 5 L was mis-packaged as size 6 R and vice versa. Smith & Nephew Inc
Food Serene Science/Source Naturals brand GABA (Gamma-Aminobutyric Acid), CALM MIND, A dietary supplement, 45 Tablets, Item #: SN0237; 90 Tablets, Item #: SN0240; 180 Tablets, Item #: SN0268; Product label states, "manufactured for Source Naturals, Inc., P.O. Box 2118, Santa Cruz, CA 95062"; and distributed by Threshold Enterprises, Ltd, Scotts Valley, CA; The product is actually manufactured by a Contract Manufacturer: Abco Laboratories, Inc., 2450 S. Watney Way, Fairfield, CA 94533 Item #: SN0237 - 45 Count, Lot Numbers: FG-40244, FG-40421, FG-40679; Item #: SN0240 - 90 Count, Lot Numbers: FG-40245, FG-40422, FG-40680; Item #: SN0268 -180 Count Lot Number: FG-40681; All packages have BEST BY DATE 3/21/17 Class II The firm found small piece of metal fragment in one tablet during its inspection process. Threshold Enterprises Ltd
Devices da Vinci Vision System Cart, a component of the da Vinci Si Surgical System IS3000; Y1903 Illuminator (Illuminator + Lamp Module); Y1902 Replacement Lamp Modules. Intuitive Surgical, Sunnyvale, CA. As a component of the IS3000 da Vinci Si Surgical System, the 3DHD Vision System provides a high resolution image for the surgeon (at the 3D viewer) and the patient-side assistant (at the touchscreen). The 3DHD endoscope assembly (endoscope and camera head) can be used manually (that is, handheld, as with a traditional endoscopy cart) or can be mounted on the camera arm to assist with preoperative exploration. Also integrated in the Vision System Cart is the Illuminator. The illuminator has a single light source attached to the endoscopy assembly by the light guide cable. It provides illumination inside the body for vision of the surgical field. The Illuminator monitors the life left on the lamp module and notifies the customer when replacement is recommended. Model # 380990 Y1903 (PN951183-05) Illuminators shipped with lamp module with coated housing. Serial numbers: 11K1903D7944 11K1903D7949 11K1903D7950 11K1903D7951 11K1903D7952 11K1903D7953 11K1903D7954 11L1903D7989 11L1903D7990 11L1903D7991 11L1903D7992 11L1903D7993 11L1903D7994 11L1903D7995 11L1903D7996 11L1903D7997 11L1903D7998 11L1903D7999 11L1903D8000 11L1903D8001 11L1903D8002 11L1903D8003 11L1903D8004 11L1903D8005 11L1903D8006 11L1903D8007 11L1903D8008 11L1903D8009 11L1903D8010 11L1903D8011 11L1903D8012 11L1903D8013 11L1903D8014 11L1903D8015 11L1903D8016  ...
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Class III Intuitive has identified that the metalized coating on the IS3000 HD lamp module may be incompatible with the illuminator control board, leading to an erroneous red Preventive Maintenance Message that shows up on monitors. Intuitive Surgical, Inc.
Food KCB Pista Khatie KCB Bakery Products Corp. 56-28 56th Street, Maspeth, NY 11378 Tel: (718) 786-9463 Fax (718) 361-0171 www.kbcusa.com a) Net Wt. 30 OZ (850 G) b) Net Wt. 13 OZ (369 G) Packaged in a plastic clam shell container with stick-on labels. Use By Date: 16 May 14; 13 oz. package UPC Code: 12042 00129; 30 oz. package UPC Code: 12042 00296 Class I The firm's Pista Khatie cookies with use by date 16 May 14 were tested by the Canadian Food Inspection Agency (CFIA) and found to contain 70 ppm of undeclared egg allergen. The label for this product states that it does not contain eggs. Kashmir Crown Baking LLC
Devices ORBIT PT. The ORBIT PT works in conjunction with an TRUMPF mobile operating table to automate the patient transport process. Item No. 1275499, Serial No. 100711351 Class III An odor and smoke developed - The cause was determined to be a power supply unit sitting in the controller column. Trumpf Medical Systems
Devices US Safire Duo Ablation Catheter MediGuide Enabled, REF A700240 and Cool Path Duo Ablation Catheter, MediGuide Enabled REF A700244, Rx only, Sterile EO. The catheters are intended for use with a compatible external irrigation pump and the IBI-15500T9-CP RF Generator at a maximum of 50 Watts. MediGuide Enabled Ablation catheters are used with the MediGuide Technology to enable real-time tip positioning and navigation and in conjunction the the EnSite Velocity System. The MediGuide Technology is indicated for use as an adjunct to fluoroscopy. Catalog Number A700244 Batch Number 4113241. Catalog Number A700240 Batch Number 4113242. Class II St. Jude Medical Cardiovascular and Ablation Technologies Division is performing a voluntary notification regarding selected batches of Coolpath Duo Ablation Catheter MediGuide Enabled products and Safire Duo Ablation Catheter MediGuide Enabled. These units were inadvertently shipped with the incorrect version of the Instructions for Use (IFU). St. Jude Medical
Food Dual Action Cleanse by Cellular Research Formulas, 60 ct, Item AN027370, UPC 7 10363 27370 5, Item AN056592HFS, UPC 7 10363 56592 3; Item DR056439, UPC 7 10363 57369 0. Lot # T3F006 Class II Irwin Naturals is recalling Daily Digestive Enzymes and Dual Action Cleanse because they may possibly be contaminated with chloramphenicol. Irwin Naturals
Food Dual Action Cleanse by Cellular Research Formulas with Green Tea Bonus 60 ct, Item AN056906E, UPC Code: 7 10363 56906 8 Lot #T3G017 Class II Irwin Naturals is recalling Daily Digestive Enzymes and Dual Action Cleanse because they may possibly be contaminated with chloramphenicol. Irwin Naturals
Food Irwin Naturals Daily Digestive Enzymes 45 ct, Item IN057552, UPC Code: 7 10363 57552 6 Lot #S3C013 Class II Irwin Naturals is recalling Daily Digestive Enzymes and Dual Action Cleanse because they may possibly be contaminated with chloramphenicol. Irwin Naturals
Drugs Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL single patient infusion vial packaged in 5 Units x 20 mL per carton, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-4699-30. Lot #: 27-570-DJ, Exp 03/01/15 Class II Presence of Particulate Matter: Visible particles embedded in the glass identified during a retain sample inspection. Hospira Inc.
Devices VitreaCore® software. Versions subject to the limitation: 6.0, 6.1, 6.2, 6.3 (except 6.3.1 ), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. The VitreaCore (ViTALConnect) system is a medical diagnostic software system intended to process, analyze, review, and distribute multi-dimensional digital Images acquired from a variety of imaging devices including: CT, MR, CR/DR/DX, SC, US, NM, PET, XA, and RF, etc. The VitreaCore (ViTALConnect) is not meant for primary Image Interpretation In mammography. Serial Number 540819 5040918941 CRB1209125 540837 541722 CRB1107015 541783 CRB1211144 540638 CRB1110030 CRA1107015 541350 5060218759 3070900036 540864 CRU1302045 540935 345221 CRB1206107 CRB1108021 540970 540249 CRB1211148 CRB1105014 CRB1203085 CRB1212173 541173 3070900134 373677 541633 5080115149 540621 541631 541578 542109 5080111321 5090109540 5080109815 541808 CRU1303050 5080105909 5090102074 5060218090 541618 CRU1303046 CRB1211141 CRU1203031 CRU1209037  ...
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Class II Vital Images, Inc. has found an issue in VitreaCore software though internal testing. There is a potential for incorrect and possibly reversed image orientation for certain snapshots taken in VitreaCore software versions 6.0, 6.1, 6.2, 6.3 (except 6.3.1), 6.4 (except 6.4.4 and 6.4.5), as well as their upgrades, and 6.5. Vital Images, Inc.
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