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U.S. Department of Health and Human Services

Enforcement Report - Week of October 23, 2013

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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Biologics Fresh Frozen Plasma 07FJ84940(Parts A, B and C); 07GJ13755(Parts A, B and C) Class III Fresh Frozen Plasma products, not manufactured in accordance with GMPs, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 3521967 Class II Blood products, collected from a donor who immigrated from a malarial endemic country, were distributed. Community Blood Bank, Inc.
Biologics Platelets Q33179/1, Q34253/1, Q35248/1, Q37672/1 Class II Blood products, collected from a donor who was previously deferred, were distributed. Cedars-Sinai Medical Center
Biologics Salvaged Plasma for Non-Injectables J04852/2, M19247/1, M20753/1, M22181/1, M24146/1, N26282/1, N28776/1, Q36267/2, R39866/1, S45532/1, N87396/1, N94495/1 Class II Blood products, collected from a donor who was previously deferred, were distributed. Cedars-Sinai Medical Center
Devices Dimension Vista (R) Urinary/Cerebrospinal Fluid Protein (UCFP) Flex (R) Reagent Cartridge Lot 11349BB The Urinary / Cerebrospinal Fluid Protein method is an in vitro diagnostic test for the quantitive measurement of protein in urine and cerebrospinal fluid on the Dimension Vista System. Lot No. 11349BB Class II Siemens has confirmed an increase on absorbance errors when calibrating Dimension Vista Urinary/Cerebrospinal Fluid Protein (U CFP) Flex Reagent Cartridge lot 11349 BB. Siemens Healthcare Diagnostics, Inc.
Biologics Red Blood Cells Leukocytes Reduced W043212088253; Class II Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Assurance Inc
Biologics Blood and Blood Products for Reprocessing W043212088253; Class III Blood products, collected from a donor whose suitability to donate was not adequately determined, were distributed. Blood Assurance Inc
Biologics Platelets Pheresis Leukocytes Reduced W221613606689; W221613606689; Class II Blood products, labeled leukoreduced without the assurance that they met the criteria for leukoreduced products, were distributed. Central Texas Regional Blood & Tissue Center
Biologics Platelets Pheresis Leukocytes Reduced 36GN35318; Class II Blood product, labeled as leukoreduced which did not meet the requirements for a leukoreduced product, was distributed. The American National Red Cross South Carolina Region
Biologics Platelets Pheresis Leukocytes Reduced W038113118478; Class II Blood product, labeled with an extended expiration date, was distributed. OneBlood, Inc.
Biologics Red Blood Cells Leukocytes Reduced W070512317619; Class II Blood product, collected from a donor who visited a malarial endemic area, was distributed. Stanford Medical School Blood Center
Biologics Source Plasma 5090228467; 5090228223; 5090228119; 5090226910; 5090226796; 5090226028; 5090225871; 5090225544; 5090226780; 5090225645; 5090225505; Class III Blood products, collected from donors whose donor suitability was not adequately determined, were distributed. Talecris Plasma Resources
Biologics Cornea 027713ODE01 Class III Mislabeled human cornea was distributed. Lions Medical Eye Bank & Research Center of Eastern VA
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced W041110029635Q; Class II Blood product, incorrectly determined to be negative for the Fya antigen, was distributed. Blood Systems, Inc. dba United Blood Services Texas
Devices ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide connected to it, SMN 10361162 and SMN 10361798 --- CLASSIFICATION NAME: Counter, Differential Cell, Automated (Particle Counter) The ADVIA 2120/2120i are hematology systems that utilizes the principles of flow cytometry in order to provide complete blood counts. All serial numbers connected to the ADVIA 2120/2120i Hematology Systems with ADVIA Autoslide. Class II Siemens determined that if an autosampler rack jam error occurs during operation of an ADVIA 2120/2120i connected to an ADVIA Autoslide, it is possible that the next slide processed by the Autoslide could be labeled with the wrong sample identification information. Siemens Healthcare Diagnostics
Devices Synthes Midfoot Fusion Bolt 6.5 mm. It is indicated for fracture, fixation, osteotomies, nonunions, and fusions of large bones in the foot and ankle. Part Nos.: 04.111.210, 04.111.220, 04.111.230. with Lot Nos.; 2294209 through 7587547. Class II A post market safety review following several customer complaints indicated additional clarification was necessary in the Midfoot Fusion Bolt Technique Guide to reduce potential for bolt back-out or migration by emphasizing the need for supplemental fixation. Synthes USA HQ, Inc.
Devices GE, Optima CT660. Intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data. Mfg Lot or Serial # 00000426724CN1 00000429656CN2 00000429809CN7 00000430378CN0 00000430460CN6 00000430480CN4 00000430489CN5 00000430646CN0 00000430650CN2 00000430651CN0 00000430737CN7 00000430795CN5 00000430813CN6 00000430951CN4 00000431016CN5 00000431035CN5 00000431141CN1 00000431269CN0 00000431307CN8 00000431350CN8 00000431506CN5 00000425485CN0 00000424498CN4 00000427441CN1 00000428100CN2 00000429970CN7 00000430427CN5 00000431140CN3 00000431442CN3 00000425128CN6 00000425032CN0 00000428566CN4 00000431662CN6 00000431604CN8 00000431721CN0 00000431708CN7 00000428762CN9 00000428780CN1 00000429600CN0 00000429658CN8 00000429818CN8 00000429877CN4 00000430132CN1 00000430186CN7 00000430264CN2  ...
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Class II GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID, although all images are correctly annotated. This issue can cause additional images from a different patient and images from two or more patients to appear in one exam. GE Healthcare, LLC
Devices GE PET Discovery 610, PET Discovery 710. Intended for head and whole body attenuation corrected Positron Emission Tomography (PET) imaging. MfgLotorSerial# 00000428413CN9 00000429077CN1 00000429247CN0 00000430152CN9 00000430656CN9 00000430999CN3 00000431369CN8 00000429701CN6 00000430064CN6 00000431187CN4 00000429354CN4 00000431447CN2 00000293950HM2 00000429821CN2 00000429946CN7 00000430001CN8 00000293950HM2 00000430632CN0 Shipped Shipped Shipped 00000429572CN1 00000428755CN3 00000428755CN3 00000428868CN4 00000293949HM4 00000428536CN7 00000429820CN4 Class II GE Healthcare has recently become aware of a potential safety issue related with the DMPR function and Screen Saved Images on your scanner which involves Optima CT660, Brivo CT385, Discovery PET/CT 610, Discovery PET/CT 710. The DMPR and Screen Save functionality may possibly generate the same Series UID. It has been seen that some PACS may combine series under a patient using only the Series UID, although all images are correctly annotated. This issue can cause additional images from a different patient and images from two or more patients to appear in one exam. GE Healthcare, LLC
Biologics Cornea CW102297OD; CW102297OS Class III Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. Eye Bank Of Wisconsin, Inc.
Devices Getinge 46-Series Medical Washer-Disinfectors, Listing # E208196 Product Usage: The washer disinfector is used in healthcare facilities where reusable items such as instruments, utensils, anesthesia sets, and glassware are handled for decontamination purposes. Model # 46-4, Serial # range SEV0521184-SEV0838137 Class II Getinge Disinfection AB initiated a voluntary field safety correction for the Getinge 46-Series electrically-heated Washer Disinfectors due to possible overheating. Getinge Disinfection
Biologics Birch, White B44060111A Class III Allergenic Extracts, reprocessed by an unapproved process, were distributed. Antigen Laboratories Inc
Devices Clinical Chemistry Phosphorus Reagent The Phosphorus assay is used for the quantitation of phosphorus in human serum, plasma, or urine. For List Number: 7D71-22, Lot Numbers 64736UN12 (Exp Date on Label is 14 JAN 2014), 03991UN13 (Exp Date on Label is 01 APR 2014), and 51611UN13 (Exp Date on Label is 13 JUL 2014). For List Number: 7D71-31, Lot Numbers 74805UN12 (Exp Date on Label is 14 JAN 2014) and  ...
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Class II Reagent lots 64736UN12, 03991UN13, 51611UN13, 74805UN12, and 03992UN13 have incorrect expiration dates assigned by Supplier. Abbott Laboratories, Inc
Food Hartley's Potato Chips Salt & Vinegar 4.5 oz and 2.5 oz bags Hartley's Potato Chip Co., Inc, Lewistown, PA Ingredients: potatoes, vegetable shortening, salt, lactose, sodium diacetate, salt, malic acid, sodium citrate, with not more than 2% silicon dioxide and partially hydrogenated soybean and/or cottonseed oil. Sell by Dates: Oct 7 2013 and Oct 30 2013 Class I Undeclared lactose (milk) in seasoning sub-ingredient used in the manufacturing of Hartley's Salt & Vinegar Potato Chips. Hartleys Potato Chip Company Inc
Devices Boston Scientific COGNIS CRT-D, Cardiac Resynchronization Therapy Defibrillator, models N118, N119. The following models are not available in the US: models N106, N107, P106, P107. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. Model N118, Serial numbers: 559191, 559192, 559195, 559196, 559200, 559201, 559202, 559203, 559210, 559211, 559212, 559215, 559222, 559223, 559225, 559226, 559231, 559232, 559236, 559238, 559239, 559240, 559241, 559242, 559245, 559247, 559250, 559251, 559253, 559257, 559260, 559262, 559263, 559266, 559267, 559272, 559273, 559275, 559277, 559278, 559279, 559281, 559282, 559283, 559286, 559289,  ...
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Class II The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion. Boston Scientific CRM Corp
Devices Boston Scientific TELIGEN, Implantable Cardiac Defibrillator models E102, E110, the following models are not available in the US: models F102, F110, F111. Sterilized using ethylene oxide. Boston Scientific, 4100 Hamline Avenue North, St. Paul, MN 55112-5798 USA. Indicated for patients who are at risk for sudden cardiac death due to ventricular arrhythmias and may require pacing support. Model E102, Serial Numbers: 000138, 000139, 000140, 000142, 000145, 000146, 000147, 000151, 000152, 000153, 000154, 000161, 000162, 000163, 000166, 000167, 000169, 000170, 000172, 000173, 000174, 000175, 000176, 000177, 000178, 000182, 000183, 000184, 000185, 000187, 000188, 000191, 000192, 000193, 000194, 000196, 000199, 000200, 000202, 000203, 000204, 000207, 000209, 000210, 000213, 000214,  ...
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Class II The performance of a low voltage capacitor in a subset of COGNIS CRT-Ds and TELIGEN ICDs manufactured prior to December 2009, may be compromised over time, causing increased current drain that can lead to premature battery depletion. Boston Scientific CRM Corp
Devices MX 16-Slice CT Scanner System. Used as a whole-body computed tomography X-Ray system. Model # 728131  510(k) K083498  Serial #: EP16E090001, EP16E090002, EP16E090003, EP16E090006, EP16E090009, EP16E090010, EP16E090011, EP16E090012, EP16E090013, EP16E090015, EP16E100001, EP16E100004, EP16E100006, EP16E100008, EP16E100010, EP16E100012, EP16E100013, EP16E100016, EP16E100017, EP16E100018, EP16E100019, EP16E100020, EP16E100021, EP16E100022, EP16E100023, EP16E100024, EP16E100025, EP16E100026, EP16E100028, EP16E100029, EP16E100031, EP16E100032, EP16E100033, EP16E100034, EP16E100035, EP16E100037, EP16E100038, EP16E100039, EP16E100041, EP16E100043, EP16E100044,  ...
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Class II A pinch point at the end of the table top can cause injury. Philips Medical Systems (Cleveland) Inc
Devices GE Healthcare, Avance, Avance CS2, Aisys, Aespire View, and Engstrom. Intended for volume or pressure control ventilation. Mfg Lot or Serial # APHS00701 APHS00802 APHS00729 APHS00730 APHS00700 APHS00692 APHS00932 APHS00886 APHS00861 APHS00865 APHS00866 APHS00867 APHS00868 APHS00887 APHS00888 APHS00860 APHS00881 70138420 - 1 APHS00844 APHS00711 APHS00712 5324664 - 1 APHS00703 APHS00704 5328496 - 1 APHS00690 APHS00719 APHS00720 APHS00722 APHS00723 APHS00828 APHS00834 APHS00835 APHS00836 APHS00843 APHS00809 APHS00854 APHS00855 APHS00856  ...
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Class I GE Healthcare has recently become aware of a potential safety issue involving unresponsive buttons on the display of the Engström ventilator and the Aespire View, Aisys, and Avance anesthesia machines. As a result of a manufacturing issue, the buttons on the left, right, and bottom keypads may not always detect button presses. This may result in the inability to access certain menu functions which could possibly lead to delay in treatment. GE Healthcare, LLC
Food Talenti German Chocolate Cake Gelato, One Pint (473 mL), Crafted By: Talenti, Marietta, GA 30062. Lot #: BEST BY DATE of 11/04/2014 M1, 11/24/2014 M1, and 11/24/2014 M2 on the bottom of the container; UPC #: 1 8685200063 1. Class II Product contains undeclared Allergen; Almonds. Talenti Gelato
Devices GE Healthcare, Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ. Intended for general purpose diagnostic fluoroscopy and radiography studies. Mfg Lot or Serial # System ID 00000026767YY4 201982LCA 00000068001YY7 901384LCA 00000033988YY7 914737LCA 00000034024YY0 954LCA1 00000031679YY4 708216LLCA 00000952037WK0 630856LCN 00000320794BU1 082406010002 00000346260BU3 DR-27820-CO 00000991021WK7 LB1160VA01 00000058879BU8 930047946 00000484712WK5 1453 00000529468WK1 915685LCA 00000528385WK8 082406040003 00000526149WK0 66324TC 00000497670WK0 M4017051 00000512202WK3 1616LCA 00000528587WK9 62134LCV+ 00000533252WK3 00001VAS01 00000548229WK4 506857LCA 00000088970BU9 0910063030 00000233847BU3 082406030001 00000238390BU9  ...
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Class II GE Healthcare has become aware of a potential safety issue involving missing screws in the overhead Video Monitor Suspension of the Advantx, Innova 2000, Innova 2100IQ, Innova 3100, Innova 3100IQ, Innova 4100, Innova 4100IQ Cardiovascular X-ray imaging systems. GE Healthcare, LLC
Devices Harvest Graft Delivery System; Model Number: GDP-10 Product Usage: The Harvest Graft Delivery System is intended for the aspiration of bone marrow, autologous blood, plasma, or other body fluids. The system is indicated for die delivery of allograft, autograft, or synthetic bone graft materials to an orthopedic surgical site. In addition, it is designed to facilitate pre-mixing of bone graft materials with the aspirate(s), I.V. fluids, blood, plasma, platelet rich plasma, bone marrow or other specific blood component(s) as deemed necessary by the clinical use requirements. GDP-10-0046, GDP-10-0047, GDP-10-0048, GDP-10-0050, GDP-10-0051, GDP-10-0052, GDP-10-0053, GDP-10-0054, GDP-10-0055, GDP-10i-0010 Class II Potential for leur connector to leak or have cracks. Harvest Technologies Corporation
Drugs Concentrated Motrin (ibuprofen) Infants' Drops Oral Suspension, Original Berry Flavor 1/2 fl oz bottles, 50 mg per 1.25ml, Distributed by McNeil Consumer Healthcare, Fort Washington, PA. Lot #: DCB3T01, DDB4R01, and DDB4S01, Exp 03/31/15 Class II Presence of Foreign Substance: process-related particulates which may be associated with the raw materials were observed Mcneil Consumer Healthcare, Div Of Mcneil-ppc, Inc.
Devices GE Healthcare, Precision 500D, Legacy, RFX, and SFX X. This table is intended for use in a diagnostic X-ray system to support patients during general purpose radiological procedures in the horizontal, vertical and trendelenburg positions. - The Expedio 500D is designed to perform radiographic and fluoroscopic x-ray examinations. - The Precision 500D R&F X-ray System is intended to be used as a universal diagnostic imaging system for radiographic and fluoroscopic examinations, including general R&F and pediatric examinations. The Precision 500D R&F X-ray Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic and fluoroscopic exposures of the whole body, skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Serial # System ID 00000976624WK7 202884RF2410 00000977748WK3 202884RF2411 00000955594WK7 205877LRF2 00000965983WK0 207373RF1 00000969026WK4 215748LEG1 00000960066WK9 219416ADV 00000975683WK4 228809SR2 00000966338WK6 256235ORF1 00000967770WK9 301896RF 00000961102WK1 302654RF 00000972383WK4 303440BCHRM4 00000964398WK2 303730R3 00000958345WK1 304256RX1A 00000978812WK6 361552LEGD1 00000970377WK8 404321LEG2 00000973016WK9 408259RF1 00000963305WK8 408977RF5 00000963524WK4 414266RM03 00000963118WK5 417533BR2 00000969537WK0 507372LEG 00000959491WK2 518382SRM2 00000976668WK4 540862ARF6 00000966773WK4 561468RM4  ...
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Class II GE Healthcare has recently become aware of a potential safety issue involving the spotfilm device power assist handle. There is a potential for the internal bolts on the power assist handle to be loose or to loosen and/or fall out. This issue, if present, can result in a loss of calibration and offset of the power assist handle and/or, under extreme condition, sticking of the handle in the ON position. These conditions could cause the system to strike the patient. No injuries have been reported to date related to this issue. GE Healthcare, LLC
Food Honey Roasted Peanuts, net wt. 11 oz.., packed in a clear plastic bag. Ingredients: peanuts, sugar, peanut and/or canola and/or cottonseed oil, honey, salt, modified potato starch, xanthan gum. Allergen info: peanut and soy ingredients. Also states that facility also processes products containing, milk and wheat ingredients. Distributed by: Dutch Valley Food Distributors Inc., Myerstown, PA 17067. All products with UPC code 8 77245 00143 3 and Best By date up to 1/21/14. Class II Honey Roasted Peanuts were recalled due to undeclared milk (lactose) and wheat (wheat starch) allergens in the ingredient statement. Dutch Valley Food Development Inc.
Food Roasted Salted Mixed Nuts w/ Peanuts, net wt. 12 oz., packed in a clear plastic bag. Ingredients: blanched peanuts, unblanched peanuts, unblanched almonds, unblanched Brazil nuts, unblanched filberts, cashews cooked in canola oil, salt. Allergen info: peanut and tree nuts (almonds, Brazil nuts, filberts, cashews). Labeling also states that the facility also processes products containing tree nuts. Distributed by Dutch Valley Food Distributors Inc., Myerstown, PA 17067. All products with UPC code 8 77245 00140 2 and Best By date up to 1/21/14. Class II Roasted Salted Mixed Nuts with Peanuts were recalled for undeclared tree nuts (pecans) in the ingredient statement. Dutch Valley Food Development Inc.
Devices Product Name: OSOM C. Difficile Toxin A/B Test Catalog Numbers: 173 (for United States) and 173 E (for Europe). The Test is a qualitative assay (in vitro diagnostic) that employs immunochromatographic, dipstick technology. If C. difficile toxin A or toxin B is present, a blue/gray line will appear in the test line region indicating a positive result. A red control line must appear for the results to be valid. If C. difficile toxins are not present, only the red control line will appear. An invalid test occurs when no control line appears The Test is intended for the qualitative detection of Clostridium difficile toxins A and/or B in human stool samples. This test is intended as an aid in the diagnosis of C.difficile associated disease (CDAD) in patients with symptoms of CDAD. The following are part numbers and lot number combinations. PN:173E, LN:121272. PN:173, LN:121273. PN:173, LN:121273A. PN:173E, LN:131155. PN:173, LN:131156. Class II Sekisuki Diagnostics has issued a Product Correction for certain lot numbers of the OSOM C. difficile Toxin A/B Test Kit, because it has been determined that there is potential for false negative results. Sekisui Diagnostics LLC
Devices Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) Brilliance CT Big Bore Oncology, Brilliance CT Big Bore Radiology and Brilliance CT 16 (Air) scanners are whole body Computed Tomography X-ray systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient and equipment supports, components and accessories. System Code #728243, Serial #: 7040, 7083, 7087, 7123, 7124, 7133, 7170, 7178, 7204, 7231, 7273, 7328, 7365, 7370, 7395, 7434, 7467, 7596, 7612, 7775, 7794, 7795, 7840, 7841, 7842, 7843, 7846, 7847, 7848, 7849, 7850, 7851, 7852, 7854, 7855, 7856, 7857, 7858, 7860, 7861, 7863, 7864, 7865, 7866, 7867,  ...
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Class II There are artifacts appearing on the Tracker images during threshold-triggered bolus scans with protocols using a Rotation Time of 0.4 seconds. Philips Medical Systems (Cleveland) Inc
Food Wegmans Bakery Mini Muffins APPLE CINNAMON, NET WT 14 OZ (397g) , UPC 77890 18951 --- Baked By Wegmans Food Markets Inc., Rochester, NY 14603 All date codes up to and including "Best if used by 9/24/13" Class I The Apple Cinnamon Mini Muffins contain undeclared soy, a known allergen. Wegmans Food Markets
Devices GE Healthcare, Aisys, Amingo, Avance, and Avance CS2. Intended for volume or pressure control ventilation. Mfg Lot or Serial # ANBR01060 ANAQ01557 ANBQ01421 ANBQ01418 ANBQ01419 ANBQ01420 ANBR01342 ANBR00292 ANBR00289 ANBR00293 ANBR00290 ANBR00291 ANBR00294 ANBR00295 ANBQ01522 ANBQ01520 ANBQ01524 ANBQ01521 ANBQ01523 ANBQ02209 ANBQ02212 ANBQ02213 ANBQ02210 ANBQ02211 ANBS00535 ANBR01079 ANBR01078 ANBR01080 ANAQ00842 ANBR01053 ANBR01054 ANBQ01015 ANBQ01965 ANBQ01480 ANBQ01966 ANBQ01484 ANBS00304 ANBS00305 ANAR00675 ANAR05794 ANAR05793 ANBQ01751 ANBR00248 ANAS00596 ANAS00593  ...
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Class I GE Healthcare has recently become aware of a potential safety issue involving the Avance, Avance CS2, and Aisys anesthesia devices. While operating in Pressure Control Ventilation  Volume Guarantee (PCV-VG) mode, the affected products may produce an over delivery tidal volume when given a unique sequence of user inputs and a collapsed bellows (partially filled circuit). Exposure to excessive tidal volumes while pressure limits are maintained can result in pulmonary volutrauma and/or an increased pulmonary vascular resistance that can negatively affect cardiac filling pressure and/or stroke volume. GE Healthcare, LLC
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