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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, 980, 981, 982, 983, 984, 1017, 1018, 1019, 1020, 1021, 883, 884, 885, 886, 1012, 1013, 1014, 1015, 1016, 1027, 1028, 1029, 1030, 1031, 941, 942, 943, 944, 945, 946, 947, 948, 949, 950, 903, 904, 905, 906, 907 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 failing ivermectin potency: 120378, 03/2014; 120090, 01/2014; 120301, 02/2014; 120305, 02/2014; 120692, 05/2014 ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: 121282, 10/2014 and 120450, 02/2014. Worm Sheild Lot numbers and expiration dates of recalled product failing ivermectin potency: 120090, 01/2014; 120301, 02/2014; 120305,02/2014. ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: 120450, 04/2014 Heartshield Lot numbers and expiration dates of recalled product failing ivermectin potency: 120692, 05/2014. ****Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: NONE 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 and 120831, exp 06/2014. Wormshield- 120093, exp 01/2014 and 120824, exp 06/2014. Heartshield- 120831, exp 06/2014. Lot numbers and expiration dates of recalled product with passing potentcy but expected to fail: Iverhart Plus- 120127, exp 02/2014; 120207, exp 02/2014; 120256, exp 01/2014; 120289, exp 02/2014; 120300, exp 02/2014; 120306, exp 02/2014; 120434, exp 03/2014; 120464, exp 04/2014; 120678, exp 05/2014; 121110, exp 07/2014; 121150, exp 09/2014; 121283, exp 10/20; and 14121386, exp 10/2014. Wormshield- 120464, exp 04/2014; 120649, exp 04/2014 and 120678, exp 05/2014. Heartshield- 120811, exp 05/2014. 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. No. TF8-32-63-37, Lot TFFB290113; Part No. TF8-32-63-45, Lot TFFA290113; Part No. TF8-32-63-45, Lot TFFB310812; Part No. TF8-32-63-45, Lot TFFC221211; Part No. TF8-32-63-55, Lot TFFA051212; Part No. TF8-32-63-55, Lot TFFA230812; Part No. TF8-32-63-55, Lot TFFB221211; Part No. TF8-32-63-55, Lot TFFB230113; Part No. TF8-32-63-90, Lot TFFA070213; Part No. TF8-32-63-90, Lot TFFA070912; Part No. TF8-32-81-135, Lot TFFH070912; Part No. TF8-32-81-37, Lot TFFD070912; Part No. TF8-32-81-45, Lot TFFE070912; Part No. TF8-32-81-55, Lot TFFF070912; Part No. TF8-32-81-90, Lot TFFG070912; Part No. TF8-38-62-S, Lot TFFA201212; Part No. TF85-32-63-37, Lot TFFC070912; Part No. TF85-32-63-45, Lot TFFA221211; Part No. TF85-32-63-45, Lot TFFA250512; Part No. TF85-32-63-45, Lot TFFC051212; Part No. TF85-32-63-45, Lot TFFC230812; Part No. TF85-32-63-55, Lot TFFA230113; Part No. TF85-32-63-55, Lot TFFA290812; Part No. TF85-32-63-55, Lot TFFB070612; Part No. TF85-32-63-90, Lot TFFB230812; Part No. TF85-32-63-90, Lot TFFC260413; Part No. TF85-32-63-90, Lot TFFC280213; Part No. TF85-32-63-90, Lot TFFF070213; Part No. TF85-32-81-135, Lot TFFC280912; Part No. TF85-32-81-37, Lot TFFA280912; and Part No. TF85-32-81-90, Lot TFFB280912 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 AS49426 AS49429 AV01023 AV01025 AM48043 AV06003 AT40542 AS15064 AT30380 AV01015 AS12050 AV06004 AV06151 AS12051 AS12052 AT01004 AU25303 AT36497 AT36499 AT36509 AV06127 AV06130 AV11231 AV14273 AV14275 AV27546 AV06141 AV01009 AV05104 AV09187 AV09192 AV09179 AU42632 AV06152 AV11238 AV14278 AV14283 AV28554 AV28559 AV23449 AV18362 AV09180 AV18364 AV24456 AV22393 AV11234 AV02072 AV05098 AV09184 AV02046 AV09191 AV09196 AV09197 AV24452 AT18242 AV09182 AV02051 AV02068 AV02076 AV06139 AV11236 AV12241 AV14287 AV28031 AV06147 AV11216 AV24490 AV26492 AV26498 AV26499 AS46412 AV12265 AV14266 AV05093 AV01032 AV14288 AV18373 AV26506 AV27512 AV02042 AU06070 AV06150 AV23424 AV26491 AV26495 AV26496 AV26500 AV26501 AV26503 AV26504 AV26505 AV27514 AV02064 AV18371 AV18375 AV01029 AV01031 AS43391 AS43392 AV01006 AV11232 AV23419 AV23423 AV28026 AV16315 AV16326 AN10031 AV01002 AV14294 AV18359 AV18365 AV27541 AV12260 AV05117 AV05120 AV27533 AV06154 AV06157 AV22386 AV28028 AV28595 AT44622 AV11202 AV27542 AV28564 AV22388 AT24332 AT27337 AV24467 AT42590 AV02044 AV02052 AV05095 AV05107 AV05109 AT27347 AN10025 AN20049 AS40359 AV12245 AV12247 AS24192 AV16337 AV16339 AU47779 AV14271 AN30064 AN30070 AV24457 AV24458 AV27537 AT02042 AU40574 AV14295 AT48660 AV23422 AT27343 AV28561 AN07022 AN10027 AT27345 AV02061 AT23288 AN42123 AT21265 AV27544 AV02070 AT18248 AV16336 AV06148 AV11221 AV11227 AV01008 AU05052 AV18358 AV18369 AV24465 AV24466 AV05096 AV01035 AV01038 AT23274 AV05099 AV18349 AV18366 AV28033 AV23439 AV24455 AV28029 AV28030 AU02003 AV05085 AV06140 AV22407 AV23430 AV27524 AV27528 AV28580 AV09172 AS27199 AS27204 AS27221 AS27222 AS30231 AS30232 AS30238 AS30242 AS30243 AS32248 AS32263 AS32264 AS32271 AS35282 AS40358 AT05074 AT09137 AT10144 AT50689 AV06145 AV11235 AV14284 AV14292 AV16327 AV16328 AV16343 AV18348 AV22390 AV23429 AV23432 AV24489 AV26494 AV27531 AV28571 AV28576 AS32249 AV02058 AT50690 AS49424 AV05108 AS35284 AV06134 AV06137 AV28557 AV28590 AS30228 AV22392 AV22387 AM51052 AV02057 AV02060 AV01036 AV24470 AV05087 AV02043 AV02049 AV06156 AV24473 AV24479 AV27515 AV27516 AV27529 AV27538 AV27540 AV16329 AV16332 AT06096 AM43032 AV11213 AV11215 AS02002 AV28566 AS23159 AU02019 AT23290 AT23297 AV27548 AS37334 AV28575 AV28582 AV01026 AV01027 AV26502 AV26510 AU49825 AV01005 AT16201 AV05118 AN33077 AT44598 AV28585 AV28592 AV14281 AV14282 AV27520 AV27522 AS24195 AS24196 AV05100 AV11203 AV11210 AV24451 AV27527 AV16321 AT30402 AT30404 AV02073 AT18228 AT18231 AV01010 AV05091 AU49823 AU49826 AV01013 AV18347 AV18353 AT40575 AV12255 AV12256 AV27523 AV27535 AT12164 AT12174 AV28579 AV28604 AV14291 AV09171 AN40110 AV01022 AV01024 AV28572 AV28577 AT36500 AV14298 AV14300 AV27534 AV27536 AV01039 AV05103 AV24476 AT40548 AT40549 AV02059 AV02074 AV11225 AV12246 AV24453 AU49824 AV01003 AT30397 AT30401 AV09195 AT24314 AT24316 AT30387 AT30394 AV02071 AV02075 AV09194 AV09198 AT06091 AT06094 AV12258 AV01007 AT23309 AV05094 AV05101 AV12253 AV12254 AV11220 AV09181 AV02047 AV02048 AN10033 AS27223 AS27225 AT27368 AT27370 AV16333 AV16335 AV24459 AV24460 AT16208 AV16313 AV16316 AT27359 AT40545 AT40555 AT40567 AT40571 AV05110 AV05115 AV06121 AT01008 AV09170 AV09178 AS12054 AT02038 AV14296 AV14299 AT18253 AT21261 AV09164 AV28563 AT27350 AT21264 AT40540 AT40544 AV09167 AT09103 AT46644 AV11212 AV11223 AS19106 AV12244 AV12257 AV12249 AV12251 AT18243 AS17096 AS37338 AS37341 AV11230 AV16341 AS15068 AU10088 AU10090 AV02045 AV16331 AV16334 AU14162 AV27539 AV12248 AV12252 AT46645 AT46647 AT46648 AV27545 AT48654 AT48655 AS27210 AS27215 AS46404 AS46406 AV16314 AV16318 AV01033 AV01037 AV11228 AV11233 AV09175 AV12264 AV06125 AV06136 AV12259 AT30385 AT30389 AU32446 AU32449 AV16312 AT18240 AT18244 AV14290 AV14305 AV16317 AV28558 AV28567 AV01040 AV24471 AV24472 AV24474 AS40363 AT23282 AT27367 AV11204 AV11209 AV11211 AN45136 AV09183 AV09199 AV11201 AV11206 AV14267 AV14268 AV01012 AV24488 AV26497 AV27518 AV27525 AV02050 AV16330 AV16340 AV23437 AT31410 AT31415 AN33082 AV01028 AV09174 AV23448 AV28598 AT31407 AT31414 AV28583 AV28599 AS49430 AV24468 AV02062 AV02063 AT40560 AV23411 AV11237 AV12262 AV27521 AT44626 AV11222 AV11224 AV28584 AV28601 AN30062 AU40556 AV18368 AV18377 AV27517 AV27526 AV14301 AV11207 AV11208 AS40365 AS40371 AV16342 AV02065 AV02069 AT21267 AT50692 AT27366 AS49425 AV14286 AV14289 AV05111 AV05116 AT09135 AT18249 AV05119 AV06123 AT36515 AV27530 AS19112 AV06159 AV09168 AS35300 AS35301 AN49156 AV24464 AV18350 AV18351 AV14297 AT27357 AV23418 AV27550 AV16320 AT16213 AT18219 AT05071 AT09106 AV18356 AV18360 AV18370 AT23304 AV18346 AV02066 AV05088 AT44619 AT24317 AV24462 AV24463 AV28573 AV28586 AV28587 AV02054 AV02055 AV02056 AV18363 AV18367 AV18372 AT50684 AV01019 AV24469 AV27532 AV28588 AV09188 AV27547 AV28552 AV23444 AT09127 AT09129 AT36503 AT36508 AV23426 AV23427 AV05105 AS37337 AS37339 AV14276 AV09189 AV09193 AV16338 AV22395 AU32447 AV16319 AT44601 AV06133 AV23447 AV28551 AV02053 AV16311 AV27511 AN38098 AN38104 AM51050 AU31414 AU31429 AT46643 AU19244 AU19251 AU14174 AT18225 AT24319 AT27342 AV02079 AN42121 AS21128 AU10103 AS27203 AS35285 AM32020 AN07021 AT27374 AT42585 AV28578 AV28591 AV23440 AV23450 AV14280 AV18376 AV14277 AV14279 AV23435 AV23442 AV23446 AV28593 AV28597 AV18378 AV18379 AV11218 AV11219 AU27366 AS21134 AV05081 AV02077 AN33078 AT40547 AN45150 AN49157 AN40119 AT31408 AS35290 AT24325 AN07019 AS36318 AV23416 AV23431 AS15075 AV06160 AS36315 AS17097 AS36306 AS37346 AS40348 AS46415 AS46417 AS15063 AV11239 AS27206 AS10039 AS35291 AN05010 AT02026 AS19102 AT16194 AS19103 AS02003 AS02004 AS10033 AV01030 AU02005 AV24313 AU23271 AV18381 AV22394 AV22396 AV22401 AV22406 AV22410 AV23412 AT36504 AU02007 AT05058 AT05063 AT16192 AT16202 AT24323 AT24326 AU12136 AU12142 AV28581 AV16309 AV16310 AV23438 AV23441 AV24454 AS17086 AS17082 AV24481 AV24483 AV16323 AV16325 AV16344 AV16345 AV18352 AV18354 AV18355 AS23168 AS23171 AU11133 AV23433 AU05036 AS37343 AS40352 AU36505 AS40356 AT23278 AU38531 AV09169 AV09173 AT27363 AS02005 AT44594 AT44605 AT44613 AS07018 AT02031 AV28574 AS30237 AU19238 AV06124 AV06135 AN40118 AN40120 AV27513 AS23154 AS30229 AT02022 AT23271 AV01001 AU12151 AT18250 AT42584 AT02027 AN45138 AU10102 AU49827 AV01004 AV11226 AV18383 AT02040 AN42124 AN49154 AV18382 AN33075 AV05089 AU14178 AT09104 AT12163 AS19119 AS21125 AU29380 AU29382 AN20057 AS32277 AT31427 AU25326 AU27333 AU27335 AN20060 AU45699 AT38519 AT38520 AS43384 AN20058 AN30066 AN40108 AT12175 AS19115 AS46402 AU32469 AU35472 AS37347 AS40364 AS40373 AT06089 AT01014 AT02036 AT02039 AT21262 AT24312 AT30406 AT31419 AT31424 AT31428 AS19113 AS21122 AS21124 AU44694 AU44695 AU44696 AS07015 AU10094 AU11110 AS40374 AT36487 AT38518 AT09102 AT10160 AT18233 AM32022 AS32269 AT30400 AV12261 AV12263 AN33079 AN38105 AV28555 AV28556 AV28562 AV23443 AT05059 AV12242 AV12243 AV16306 AV16307 AS21130 AS36324 AS37333 AS24174 AT06084 AT31441 AV01021 AT27371 AS17094 AV09162 AV09163 AV11240 AV22400 AS07029 AT24320 AT21257 AT30393 AT06079 AS17101 AS21136 AS24189 AT46650 AV16308 AT44597 AT01006 AS27211 AS27213 AV23420 AV23421 AS27202 AS30240 AS17088 AN42128 AT38527 AS17092 AT06080 AS07009 AV18357 AV18361 AV22397 AV22403 AV22404 AU02011 AV18384 AT06078 AS17093 AT18255 AU02013 AS27205 AT01018 AT02030 AV24475 AV24478 AV24480 AV05083 AV09165 AT42588 AT38532 AV01017 AV01018 AV01016 AV01020 AV06158 AV22405 AV05084 AV05090 AU40554 AV05086 AV05112 AV06146 AV05102 AU43642 AU43643 AV06142 AS21140 AV01014 AV06122 AV06128 AV14303 AV09161 AU27357 AU27363 AS49422 AU32439 AV14293 AV05106 AV06138 AT31416 AT31423 AV05113 AN40109 AN40111 AS17090 AT27341 AM51048 AS43393 AV16322 AV16324 AV05114 AV06129 AV06131 AV18374 AU49822 AV23415 AV23417 AU19245 AV09185 AV09186 AV23445 AT24330 AT36492 AT24329 AT36502 AU11129 AS23158 AU19243 AS24173 AT23286 AV12250 AV24482 AV23434 AV23428 AV01034 AV06155 AS36304 AV18385 AV22389 AV22391 AS32274 AV01011 AS36321 AV06011 AU48002 AV06010 AV06008 AV06001 AU51004 AV06007 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, 3031793, 3031794, 3031795, 3031796, 3031797, 3031798, 3032035, 3032036, 3032037, 3032038, 3032039, 3032040, 3032041, 3032042, 3032043, 3032044, 3032045, 3032046 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; 14542408; 14542416; 14542418; 14542424; 14542435; 14542436; 14542437; 14542450; 14542451; 14542460; 14542462; 14542464; 14542468; 14542469; 14542472; 14542613; 14542614; 14542616; 14542652; 14542688; 14542689; 14542692; 14542693; 14542694; 14542695; 14542696; 14542700; 14542705; 14542712; 14542713; 14542714; 14542725; 14542734; 14542737; 14542738; 14542739; 14542750; 14542878; 14542879; 14542880; 14542885; 14542960; 14542967; 14542969; 14542970; 14543048; 14543050; 14543053; 14543055; 14543059; 14543064; 14543068; 14543077; 14543086; 14543087; 14543089; 14543090; 14543091; 14543092; 14543093; 14543094; 14543095; 14543096; 14543097; 14543101; 14543106; 14543107; 14543110; 14543111; 14543112; 14543113; 14543114; 14543115; 14543117; 14543118; 14543122; 14543124; 14543125; 14543126; 14543128; 14543129; 14543130; 14543131; 14543132; 14543133; 14543134; 14543136; 14543138; 14543139; 14543144; 14543147; 14543150; 14543151; 14543155; 14543156; 14543159; 14543160; 14543164; 14543165; 14543168; 14543171; 14543172; 14543173; 14543176; 14543177; 14543178; 14543180; 14543181; 14543182; 14543183; 14543185; 14543187; 14543191; 14543192; 14543193; 14543196; 14543199; 14545700; 14545701; 14545704; 14545706; 14545708; 14545709; 14545710; 14545711; 14545713; 14545715; 14545716; 14545717; 14545718; 14545719; 14545720; 14545721; 14545722; 14545723; 14545724;14545725; 14545727; 14545730; 14545731; 14545732; 14545733; 14545734; 14545735; 14545736; 14545737; 14545738; 14545739; 14545740; 14545741; 14545742; 14545743; 14545744; 14545745; 14545746; 14545747; 14546178; 14546179; 14546180; 14546181; 14546182; 14546183; 14546184; 14546185; 14546186; 14546187; 14546188; 14546189; 14546193; 14546194; 14546195; 14546198; 14546199; 14546200; 14546202; 14546203; 14546204; 14546205; 14546206; 14546207; 14546208; 14546209; 14546210; 14546212; 14546213; 14546216; 14546217; 14546233; 14546234; 14546238; 14546239; 14546240; 14546241; 14546255; 14546261; 14546262; 14546271; 14546314; 14546334; 14546336; 14546339; 14546340; 14546343; 14546345; 14546346; 14546349; 14546356; 14546366; 14546382; 14546383; 14546409; 14546410; 14546411; 14546415; 14546424; 14546431; 14546436; 14546438; 14546448; 14546450; 14546452; 14546453; 14546466; 14546468; 14546469; 14546470; 14546471; 14546472; 14546473; 14546474; 14546475; 14546476; 14546477; 14546478; 14546479; 14546480; 14546481; 14547312; 14546902; 14546903; 14546906; 14546911; 14546914; 14546917; 14546918; 14546920; 14546923; 14546930; 14546931; 14546939; 14546940; 14546942; 14546943; 14546944; 14546950; 14546952; 14546953; 14546954; 14546955; 14546956; 14546962; 14546964; 14546965; 14546968; 14546969; 14546970; 14546971; 14546972; 14546973; 14546974; 14546975; 14546976; 14546977; 14546978; 14546979; 14546980; 14546981; 14546982; 14546983; 14546984; 14546985; 14546986; 14546987; 14546988; 14546989; 14546990; 14546991; 14546992; 14546993; 14546994; 14546995; 14546996; 14547000; 14547003; 14547004; 14547006; 14547007; 14547008; 14547010; 14547012; 14547013; 14547015; 14547016; 14547019; 14547022; 14547027; 14547033; 14547034; 14547035; 14547224; 14547225; 14547227; 14547228; 14547230; 14547232; 14547235; 14547237; 14547239; 14547240; 14547242; 14547247; 14547249; 14547251; 14547253; 14547256; 14547259; 14547260; 14547261; 14547264; 14547266; 14547267; 14547271; 14547272; 14547273; 14547274; 14547283; 14547285; 14547286; 14547289; 14547291; 14547292; 14547293; 14547294; 14547295; 14547296; 14547300; 14547302; 14547309; 14547315; 14547317; 14547318; 14547324; 14547326; 14547332; 14547339; 14547340; 14547341; 14547345; 14547522; 14547523; 14547527; 14547538; 14547539; 14547540; 14547541; 14547543; 14547544; 14547545; 14547546; 14547553; 14547557; 14547558; 14547559; 14547560; 14547562; 14547563; 14547565; and 14547566. Aquatec Ocean E-VIP Model number: 1471208 Serial numbers: 13A04000420; 13A04000421; 13A04005696; 13A04005697; 13A04005698; 13A04006199; and 13A04006200. Aquatec Ocean Dual-VIP Model number: 1525707 Serial numbers: 14543203; 14543207; 14543209; 14543211; 14543213; 14543214; 14543215; 14543216; 14543217; 14543219; 14543225; 14543227; 14543231; 14543232; 14543233; 14543234; 14543235; 14543236; 14543237; 14543239; 14543240; 14543241; 14543242; 14543243; 14543244; 14543245; 14543246; 14543248; 14543249; 14543250; 14543251; 14543252; 14543255; 14543256; 14543266; 14543267; 14543268; 14543345; 14543346; 14543347; 14543348; 14543349; 14543350; 14543351; 14543352; 14543353; 14543354; 14543355; 14543356; 14543357; 14543358; 14543359; 14543360; 14543361; 14543362; 14543363; 14543364; 14543390; 14543392; 14543395; 14543402; 14543405; 14543457; 14543458; 14543459; 14543460; 14543461; 14543462; 14543463; 14543464; 14543465; 14543466; 14543467; 14543468; 14543469; 14543470; 14543471; 14543472; 14543473; 14543474; 14543475; 14543476; 14543523; 14543525; 14543526; 14543527; 14543528; 14543529; 14543530; 14543531; 14543532; 14543533; 14543534; 14543539; 14543540; 14543541; 14543542; 14543543; 14543544; 14543545; 14543547; 14543548; 14543596; 14543597; 14543598; 14543599; 14543600; 14543601; 14543602; 14543566; 14543571; 14543572; 14543573; 14543574; 14543575; 14543577; 14543578; 14543584; 14543585; 14543591; 14543592; and 14543595. 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, ZKNBCL, ZLBBCH, ZLBBFJ, ZLBBFL, ZLCBCB, ZLCBD8, ZLDBCZ, ZLDBDM, ZLDBDV, ZLFBF7, ZLFBFB, ZLLBCR, ZLLBFT, ZLMBCH, ZLMBWD, ZLNBBF, ZLNBGZ, ZMCBDH, ZMDBCH, ZMFBC4, ZMGBBF, ZMGBC1, ZMHBBW, ZMJBHV, ZMKBBH, ZMLBCJ, ZMNBCK, ZNBBD2, ZNFBCC, ZNHBCM, and ZNLBB4. Product Codes: RLZB22D1 Lot Numbers: G4TA93, G4TC3R, G4TD5R, G4TF1X, G4TG22, G4TK21, G4TL1D, G4TM3L, G4TM84, G4TP0W, G4TT4D, G4TU2V, G4TV3T, G4TW6D, G4U17U, G4U75W, G4U795, G4UD6T, G4UF6Y, G4UG4E, G4UH49, G4UH4K, H43A3N, H43C8P, H43E9V, H43J2P, H43N12, H43N42, H43P5U, H43P9C, H43T3F, H43U78, H43V8J, H43X4K, H43Z8Y, H4453N, H44623, H4478W, H44965, H44C9G, H44D8W, H44K3G, H44K9M, H44N0X, H44R1Y, H44R4U, H44T9D, H44V39, H44W6H, H44Y24, H44Z0Y, J4A04D, J4A11V, J4A274, J4A668, J4A81X, J4A96M, J4AC6L, J4AE3P, J4AH2Z, J4AK89, J4AN34, J4AU9R, J4AW1Y, J4C35K, J4C76E, J4CE9V, K4C518, K4CE4L, K4CT8W, K4D17T, and K4D45Y. Product Codes: RLZB22DG1 Lot Numbers: G4TH90, G4TJ61, G4TP6J, G4TR76, G4TV48, G4TX1V, G4U184, G4U734, G4UD77, G4UF9V, G4UH6P, H43A3P, H43C8R, H43G7Y, H43T3K, H43U7E, H43X1G, H43Z5Y, H44645, H44H9M, H44K2T, H44L44, H44V3A, H44W6G, H44Y25, H44Z0X, H44Z3N, J4A48K, J4AA11, J4AL00, J4AR9K, and K4CE6X . Product Codes: RLZB22DGT Lot Numbers: G4U323, J4AY55, and K4C663. Product Codes: RLZB22DT Lot Numbers: G4UD92, H44D1Y, J4AY72, and K4C666. Product Codes: RLZB22T Lot Numbers: G4RE82 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 11L1903D8017 11L1903D8018 11L1903D8019 11L1903D8020 11L1903D8021 11L1903D8022 11L1903D8023 11L1903D8024 11L1903D8025 11L1903D8026 11L1903D8027 11L1903D8028 11L1903D8029 11L1903D8030 11L1903D8031 11L1903D8032 11L1903D8033 11L1903D8034 11L1903D8035 11L1903D8036 11L1903D8037 11L1903D8038 11L1903D8039 11L1903D8040 11L1903D8041 11L1903D8042 11L1903D8043 11L1903D8044 11L1903D8045 11L1903D8046 11L1903D8047 11L1903D8048 11L1903D8049 11L1903D8050 11L1903D8051 11L1903D8052 11M1903D8078 11M1903D8079 11M1903D8080 11M1903D8081 11M1903D8082 11M1903D8083 11M1903D8084 11M1903D8085 11M1903D8086 11M1903D8087 11M1903D8088 11M1903D8089 11M1903D8090 11M1903D8091 11M1903D8092 11M1903D8093 11M1903D8094 11M1903D8095 11M1903D8096 11M1903D8097 11M1903D8098 11M1903D8099 11M1903D8100 11M1903D8101 11M1903D8102 11M1903D8103 11M1903D8104 11M1903D8105 11M1903D8106 11M1903D8107 11M1903D8108 11M1903D8109 11M1903D8127 11M1903D8128 11M1903D8129 11M1903D8130 11M1903D8131 11M1903D8132 11M1903D8133 11M1903D8134 11M1903D8135 11M1903D8136 11M1903D8137 11M1903D8138 11M1903D8139 11M1903D8140 11M1903D8141 11M1903D8142 11M1903D8143 11M1903D8144 11M1903D8145 11M1903D8146 11M1903D8147 11M1903D8148 11M1903D8149 11M1903D8150 11M1903D8151 11M1903D8152 11M1903D8153 11M1903D8154 11M1903D8155 11M1903D8156 11M1903D8157 11M1903D8158 12A1903D8292 12A1903D8293 12A1903D8294 12A1903D8295 12A1903D8296 12A1903D8297 12A1903D8298 12A1903D8299 12A1903D8300 12A1903D8301 12A1903D8302 12A1903D8303 12A1903D8304 12A1903D8305 12A1903D8306 12A1903D8307 12A1903D8308 12A1903D8309 12A1903D8310 12A1903D8311 12A1903D8312 12A1903D8313 12A1903D8314 12A1903D8315 12A1903D8316 12A1903D8317 12A1903D8318 12A1903D8319 12A1903D8320 12A1903D8321 12A1903D8322 12A1903D8323 12A1903D8346 12A1903D8347 12A1903D8348 12A1903D8349 12A1903D8350 12A1903D8351 12A1903D8352 12A1903D8353 12A1903D8354 12A1903D8355 12A1903D8356 12A1903D8357 12A1903D8358 12A1903D8359 12A1903D8360 12A1903D8361 12B1903D8418 12B1903D8419 12B1903D8420 12B1903D8421 12B1903D8422 12B1903D8423 12B1903D8424 12B1903D8425 12B1903D8426 12B1903D8427 12B1903D8428 12B1903D8429 12B1903D8430 12B1903D8431 12B1903D8432 12B1903D8433 12C1903D8434 12C1903D8435 12C1903D8436 12C1903D8437 12C1903D8438 12C1903D8439 12C1903D8440 12C1903D8441 12C1903D8442 12C1903D8443 12C1903D8444 12C1903D8445 12C1903D8446 12C1903D8447 12C1903D8448 12C1903D8449 12C1903D8478 12C1903D8479 12C1903D8480 12C1903D8481 12C1903D8482 12C1903D8483 12C1903D8484 12C1903D8485 12C1903D8486 12C1903D8487 12C1903D8488 12C1903D8489 12C1903D8490 12C1903D8491 12C1903D8492 12C1903D8493 12C1903D8519 12C1903D8520 12C1903D8521 12C1903D8522 12C1903D8523 12C1903D8524 12C1903D8525 12C1903D8526 12C1903D8527 12C1903D8528 12C1903D8529 12C1903D8530 12C1903D8531 12C1903D8532 12C1903D8533 12C1903D8534 12D1903D8573 12D1903D8574 12D1903D8575 12D1903D8576 12D1903D8577 12D1903D8578 12D1903D8579 12D1903D8580 12D1903D8581 12D1903D8582 12D1903D8583 12D1903D8584 12D1903D8585 12D1903D8586 12D1903D8587 12D1903D8588 12D1903D8589 12D1903D8590 12D1903D8591 12D1903D8592 12D1903D8593 12D1903D8594 12D1903D8595 12D1903D8596 12D1903D8597 12D1903D8598 12D1903D8599 12D1903D8600 12D1903D8601 12D1903D8602 12D1903D8603 12D1903D8604 12D1903D8681 12D1903D8682 12D1903D8683 12D1903D8684 12D1903D8685 12D1903D8686 12D1903D8687 12D1903D8688 12D1903D8689 12D1903D8690 12D1903D8691 12D1903D8692 12D1903D8693 12D1903D8694 12D1903D8695 12D1903D8696 12E1903D8729 12E1903D8730 12E1903D8731 12E1903D8732 12E1903D8733 12E1903D8734 12E1903D8735 12E1903D8736 12E1903D8737 12E1903D8738 12E1903D8739 12E1903D8740 12E1903D8741 12E1903D8742 12E1903D8743 12E1903D8744. Y1902 (PN 950093-05) Replacement lamp module with coated housing; Serial numbers: 1HJD9411 1HJD9412 1HJD9415 1HJD9421 1HJD9422 1HJD9424 1HJD9465 1HJD9466 1HJD9467 1HJD9469 1HJD9470 1HJD9472 1HJD9473 1HJD9474 1HJD9475 1HJD9476 1HJD9477 1HJD9478 1HJD9483 1HJD9498 1KJD1554 1KJD1555 1KJD1556 1KJD1557 1KJD1558 1KJD1559 1KJD1560 1KJD1561 1KJD1562 1KJD1563 1KJD1564 1KJD1565 1KJD1566 1KJD1579 1KJD1580 1KJD1581 1KJD1582 1KJD1583 1KJD1584 1KJD1586 1KJD1588 1KJD1589 1KJD1590 1KJD1591 1KJD1592 1KJD1593 1KJD1594 1KJD1595 1KJD1596 1KJD1597 1KJD1599 1KJD1600 1KJD1601 1KJD1602 1KJD1603 1KJD1604 1KJD1605 1KJD1606 1KJD1607 1KJD1609 1KJD1626 1KJD1627 1LJD1831 1LJD1832 1LJD1833 1LJD1834 1LJD1836 1LJD1837 1LJD1839 1LJD1840 1LJD1841 1LJD1842 1LJD1845 1LJD1846 1LJD1847 1LJD1850 1LJD1852 1LJD1853 1LJD1854 1LJD1855 1LJD1856 1LJD1858 1LJD1859 1LJD1861 1LJD1862 1LJD1863 1LJD1864 1LJD1865 1LJD1866 1LJD1867 1LJD1868 1LJD1869 1LJD1872 1LJD1873 1LJD1874 1LJD1875 1LJD1876 1LJD1877 1LJD1878 1LJD1879 1LJD1881 1LJD1882 1LJD1883 1LJD1884 1LJD1886 1LJD1887 1LJD1888 1LJD1889 1LJD1891 1LJD1892 1LJD1893 1LJD1894 1LJD1895 1LJD1897 1LJD1898 1LJD1899 1LJD1901 1LJD1903 1LJD1904 1LJD1905 1LJD1906 1LJD1907 1LJD1908 1LJD1909 1LJD1911 1LJD1912 1LJD1916 1LJD1917 1LJD1918 1LJD1919 1LJD1921 1LJD1922 1LJD1923 1LJD1924 1LJD1925 1LJD1926 1LJD1927 1LJD1928 1LJD1929 1LJD1930 1LJD1931 1LJD1932 1LJD1933 1LJD1935 1LJD1936 1LJD1937 1LJD1938 1LJD1939 1LJD1941 1LJD1942 1LJD1943 1LJD1944 1LJD1945 1LJD1946 1LJD1947 1LJD1948 1LJD1949 1LJD1950 1LJD1952 1LJD1953 1LJD1954 1LJD1955 1LJD1956 1LJD1957 1LJD1958 1LJD1959 1LJD1960 1LJD1961 1LJD1962 1LJD1963 1LJD1964 1LJD1966 1LJD1967 1LJD1968 1LJD1969 1LJD1970 1LJD1971 1LJD1972 1LJD1973 1LJD1974 1LJD1975 1LJD1976 1LJD1977 1LJD1978 1LJD1979 1LJD1980 1MJD2854 1MJD2855 1MJD2856 1MJD2858 1MJD2859 1MJD2862 1MJD2863 1MJD2864 1MJD2865 1MJD2866 1MJD2867 1MJD2868 1MJD2869 1MJD2870 1MJD2871 1MJD2872 1MJD2873 1MJD2874 1MJD2876 1MJD2877 1MJD2878 1MJD2879 1MJD2880 1MJD2881 1MJD2882 1MJD2884 1MJD2885 1MJD2886 1MJD2888 1MJD2889 1MJD2891 1MJD2893 1MJD2896 1MJD2908 1MJD2909 1MJD2910 1MJD2911 1MJD2912 1MJD2913 1MJD2914 1MJD2915 1MJD2916 1MJD2917 1MJD2919 1MJD2920 1MJD2921 1MJD2922 1MJD2923 1MJD2924 1MJD2925 1MJD2926 1MJD2927 1MJD2928 1MJD3005 1MJD3007 1MJD3008 1MJD3009 1MJD3011 1MJD3012 1MJD3014 1MJD3016 1MJD3017 1MJD3021 1MJD3022 1MJD3023 1MJD3025 1MJD3027 1MJD3028 1MJD3029 1MJD3030 1MJD3031 1MJD3033 1MJD3034 1MJD3035 1MJD3037 1MJD3042 2AJD3454 2AJD3455 2AJD3457 2AJD3459 2AJD3460 2AJD3461 2AJD3462 2AJD3463 2AJD3465 2AJD3466 2AJD3467 2AJD3468 2AJD3469 2AJD3471 2AJD3472 2AJD3476 2AJD3477 2AJD3480 2AJD3481 2AJD3484 2AJD3485 2AJD3489 2AJD3491 2AJD3492 2AJD3493 2AJD3494 2AJD3495 2AJD3496 2AJD3497 2AJD3498 2AJD3500 2AJD3501 2AJD3502 2AJD3503 2AJD3504 2AJD3505 2AJD3506 2AJD3507 2AJD3508 2AJD3509 2AJD3510 2AJD3511 2AJD3512 2AJD3513 2AJD3518 2AJD3524 2AJD3526 2AJD3528 2AJD3533 2AJD3534 2AJD3535 2AJD3536 2AJD3537 2AJD3538 2AJD3539 2AJD3541 2AJD3542 2AJD3543 2AJD3544 2AJD3545 2AJD3546 2AJD3547 2AJD3548 2AJD3549 2AJD3550 2AJD3551 2AJD3552 2AJD3558 2AJD3559 2AJD3561 2AJD3562 2AJD3563 2AJD3564 2AJD3566 2AJD3567 2AJD3568 2AJD3569 2AJD3570 2AJD3572 2AJD3573 2AJD3575 2AJD3576 2AJD3578 2AJD3579 2AJD3580 2AJD3581 2AJD3582 2AJD3583 2AJD3584 2AJD3588 2AJD3589 2AJD3609 2AJD3612 2AJD3613 2AJD3614 2AJD3615 2BJD4398 2BJD4399 2BJD4400 2BJD4401 2BJD4402 2BJD4404 2BJD4406 2BJD4408 2BJD4409 2BJD4412 2BJD4413 2BJD4415 2BJD4416 2BJD4425 2BJD4426 2BJD4428 2BJD4431 2BJD4432 2BJD4433 2BJD4434 2BJD4435 2BJD4436 2BJD4437 2BJD4438 2BJD4439 2BJD4440 2BJD4441 2BJD4443 2BJD4444 2BJD4445 2BJD4446 2BJD4448 2BJD4449 2BJD4450 2BJD4451 2BJD4452 2BJD4453 2BJD4454 2BJD4455 2BJD4456 2BJD4457 2BJD4473 2BJD4474 2BJD4475 2BJD4476 2BJD4477 2BJD4490 2BJD4538 2BJD4539 2BJD4540 2BJD4541 2BJD4542 2BJD4543 2BJD4544 2BJD4545 2BJD4546 2BJD4547 2BJD4548 2BJD4549 2BJD4550 2BJD4551 2BJD4552 2BJD4553 2BJD4554 2BJD4555 2BJD4557 2BJD4579 2BJD4580 2BJD4581 2BJD4582 2BJD4583 2BJD4584 2BJD4585 2BJD4586 2BJD4587 2BJD4588 2BJD4589 2BJD4590 2BJD4591 2BJD4592 2BJD4593 2BJD4594 2BJD4595 2BJD4596 2BJD4597 2BJD4619 2BJD4620 2BJD4622 2BJD4623 2BJD4624 2BJD4625 2BJD4627 2BJD4628 2BJD4629 2BJD4630 2BJD4631 2BJD4632 2BJD4633 2BJD4634 2BJD4635 2BJD4677 2BJD4678 2BJD4679 2BJD4680 2BJD4681 2BJD4682 2BJD4683 2BJD4686 2BJD4687 2BJD4688 2BJD4689 2BJD4690 2BJD4691 2BJD4718 2BJD4719 2BJD4722 2BJD4723 2BJD4750 2BJD4752 2BJD4753 2BJD4754 2BJD4755 2CJD4897 2CJD4898 2CJD4899 2CJD4902 2CJD4903 2CJD4906 2CJD4909 2CJD4910 2CJD4911 2CJD4912 2CJD4913 2CJD4948 2CJD4950 2CJD4951 2CJD4953 2CJD4954 2CJD4955 2CJD4957 2CJD4958 2CJD4959 2CJD4960 2CJD4961 2CJD4963 2CJD4964 2CJD4975 2CJD4976 2CJD4979 2CJD4980 2CJD4981 2CJD4982 2CJD4983 2CJD4984 2CJD4985 2CJD4987 2CJD4988 2CJD4989 2CJD4990 2CJD4991 2CJD4992 2CJD5038 2CJD5051 2CJD5700 2CJD5743 2CJD5755 2CJD5760 2CJD5762. 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 542118 5080111550 541541 541782 542085 CRB1305211 CRB1203095 540704 541343 540693 CRB1305217 540641 541603 540322 CRB1103012 CRB1111033 CRB1112037 CRB1203084 541902 5060218686 540651 541531 541821 541997 CRB1302196 541672 542009 CRB1201048 540644 540635 CRB1203064 541554 CRB1302179 5050913152 542224 540614 542046 5060220966 540662 CRB1212154 542197 541233 540648 542195 CRB1109023 542163 541659 541590 540487 541131 CRU1212042 542204 5080122943 5090102031 5080115270 540771 CRB1212161 541645 542020 CRB1203094 CRB1302201 3070900386 CRB1203083 541605 CRB1110028 VESADLSV120900 542087 541355 3070900596 2511 542201 5041210039 5041210179 540702 CRU1303049 CRU1303051 CRU1303047 5050311950 CRB1209126 541843 3070900218 CRB1212167 541110 CRU1212043 540795 541519 CRB1201055 CRB1206108 541289 541835 541922 CRB1201050 CRB1209133 541903 50401210047 CRB1206106 CRB1203068 CRU1211040 CRB1203093 CRB1201056 3070900239 541566 540376 540839 5050911699 5080119470 CSV1303001 542082 CRU1107013 541204 541748 CRB1209121 3070900211 542095 541767 CRA1308021 542126 540552 CRB1212168 540601 5080106980 542005 CRB1109027 CRU1112026 541324 CRB1201049 540678 CRB1302181 541414 542002 541862 3070900421 CRB1305215 540241 540466 542012 CRB1206109 79178 CRB1209139 CRB1302193 541870 5080110910 CRB1209118 541538 540872 540405 CRB1203087 542000 CRB1203067 CRB1203088 CRB1203074 CRB1203079 540415 540886 CRB1302191 542193 CRB1212175 CRB1302180 CRB1212172 CRB1212162 541875 531936 CRB1203072 CRB1306239 CRB1306221 CRU1203030 540914 542175 541956 CRU1112029 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CRU1112028 540739 CRB1112034 CRB1206110 5080119381 CRB1112043 CRU1205034 541401 CRB1112042 3090900764 541480 541467 CRU1107014 CRB1302194 5080118032 542055 543843 541242 5080116781 540413 541030 5090106797 5080121610 CRB1302183 CRB1203070 CRB1212174 CRB1209137 5080122765 CRB1212169 541090 CRB1203092 CRB1203073 CRB1203082 CRB1209135 CRB1302187 541954 CRB1211145 CRU1303048 5090103364 5080121785 CRB1108018 CRB1212156 CRB1211146 540436 541105 5080116021 540555 542061 541107 CRB1212150 CRB1305216 540384 5080118377 541308 541919 541109 540488 5080118547 541129 541153 5090106614 5080121637 541455 541276 5080120045 5080119489 541236 541264 CRB1209116 541430 CRB1209134 540516 540589 541387 541292 CRB1109022 CRB1108019 541413 CRB1211147 CRB1201053 CRU1107015 543307 541443 CRU1109020 CRU1108017 CRU1109019 CRB1112041 CRB1212158 CRU1107016 CRB1305209 CRB1112038 CRB1112039 CRU1109021 CRB1209115 CRU1111023 CRB1201054 540578 CRU1112027 CRB1112044 CRB1112047 5090106622 CRB1203063 CRB1203061 CRB1302192 CRB1209128 541493 CRB1203077 CRB1206113 CRB1201057 CRB1306219 CRB1306227 CRB1209131 CRB1203066 CRB1203075 CRB1305208 5080120959 CRU1203033 CRB1203080 CRB1206101 CRB1302178 CRB1302190 CRB1209117 CRB1211140 CRB1206103 CRB1203089 CRB1209123 CRB1206099 CRB1206102 CRB1206105 CRB1206104 CRB1209132 CRB1209127 CRB1209124 CRB1206112 CRB1212159 CRB1211142 CRB1212151 CRB1305210 VRB1211143 CRB1212165 CRB1212153 CRB1212164 CRU1308052 CRB1212176 CRB1212170 CRB1306237 CRB1212171 CRB1305213 CRB1302195 CRB1302185 CRB1302188 CRB1302189 CRB1305205 CRB1302202 CRB1306225 CRB1306233 CRB1306234 CRB1306228 CRB1306229 CRB1306230 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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