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U.S. Department of Health and Human Services

Enforcement Report - Week of January 2, 2013
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Product Type Product Description Code Info Classification Reason for Recall Recalling Firm
Devices Qualicheck 1+, Aqueous Quality Control, Level 2, S7140, REF 944-042. The solution is used for quality check of blood gas analyzers. Lot R0040, expiration date February 2008; Lot R0042, expiration date April 2008. Class III The barcode for the ABL77 on the insert incorrectly enters a control range for pH of 7.90-7.95 into the analyzer. The insert correctly states that the control range is 7.40-7.45. Radiometer America Inc
Biologics Red Blood Cells (Apheresis) Leukocytes Reduced 3743751- part 1, 3743751- part 2 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced 20FC26689; 20J98938; 20LE04227; 20LE04232; 20LY55656 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. American National Red Cross
Biologics Red Blood Cells 6557165 Class II Blood product, which did not meet the acceptable product specifications, was distributed. Community Blood Center of the Ozarks
Biologics Red Blood Cells Leukocytes Reduced 21FS42335 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 21FS42335 Class II Blood products, collected from a donor with a history of Hepatitis A, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 21FV07851 Class II Blood products, collected from a donor with a history of Hepatitis, were distributed. American National Red Cross
Biologics Plasma Frozen 21FV07851 Class II Blood products, collected from a donor with a history of Hepatitis, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 30GR14000 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Blood and Blood Products for Reprocessing 30GR14000 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 21FJ45454 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Blood and Blood Products for Reprocessing 21FJ45454 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 21LH29445 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. American National Red Cross
Biologics Cryoprecipitated AHF, Pooled 21LH29445 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. American National Red Cross
Biologics Blood and Blood Products for Reprocessing 21LH29445 Class II Blood products, collected from a donor who received a tattoo within 12 months of donation, were distributed. American National Red Cross
Biologics Red Blood Cells Leukocytes Reduced 9121046 Class II Blood products, which were collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Source Plasma 366020863; 366020554; 366009883; 366009338; 366008981; 366007812; 366007488; 366006391; 366006082; 366004975; 366004698; 366000802; 366000830 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. International BioResources, LLC
Biologics Red Blood Cells Leukocytes Reduced 9122839 Class II Blood product, which was collected from a donor who traveled to a malarial endemic area, was distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Red Blood Cells Leukocytes Reduced 16LK41465 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Platelets Leukocytes Reduced 16LK41465 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Fresh Frozen Plasma 16LK41465 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. American National Red Cross (The)
Biologics Red Blood Cells Leukocytes Reduced 3711224; 3705229 Class II Blood products, which was collected from a donor who traveled to a malarial endemic area, were distributed. Community Blood Bank of Lancaster County Medical Society
Biologics Platelets 6868490 Class II Blood product, was not quarantined subsequent to receiving post donation illness information, was distributed. Community Blood Center of the Ozarks
Biologics Fresh Frozen Plasma W045007125365 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Community Blood Center Of Gtr KC
Biologics Blood and Blood Products for Reprocessing 5116010 Class II Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Community Blood Center Of Gtr KC
Biologics Blood and Blood Products for Reprocessing W045006066878 Class III Blood product, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), was distributed. Community Blood Center Of Gtr KC
Biologics Fresh Frozen Plasma W045007145917 Class II Donor Screening/Donor gave history which warranted deferral or follow up and was not deferred or follow up questions were not asked. Community Blood Center Of Gtr KC
Biologics Blood and Blood Products for Reprocessing W045007111458 Class II Blood products, collected from a donor who was at risk for variant Creutzfeldt-Jakob disease (vCJD), were distributed. Community Blood Center Of Gtr KC
Biologics Red Blood Cells Leukocytes Reduced 93GC07180; 93GC07182; 93GC07183; 93GC07184; 93GC07186 Class III Blood products, collected using a machine for which quality control testing was not performed, were distributed Mercy Medical Center Blood Bank
Biologics Source Plasma 8120001398, 8120001495, 8120001622, 8120001725, 8120001873, 8120001954, 8120002241, 8120002291, 8120002471, 8120002534, 8120002726, 8120002806, 8120003353, 8120003445, 8120003582, 8120003690, 8120003794, 8120003905, 8120004027, 8120004135, 8120004270, 8120004451, 8120004540, 8120004655, 8120004758, 8120004888, 8120004971 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. Bio-Medics
Devices Access Immunoassay Systems Total T4 Calibrators, Part Number: 33805. The Access Total T4 Calibrators are intended to calibrate the Access Total T4 assay for the quantitative determination of total thyroxine (T4) levels in human serum and plasma using the Access Immunoassay Systems. Total T4 assay results are used for diagnosis and confirmation of thyroid disorders such as hyper- and hypothyroidism. 019818, 021654, 024072 Class II A recall communication was initiated because Beckman has identified that Access Total T4 calibrator lots 019818, 021654, and 024072 do not meet their 12 month expiration date claim. Beckman Coulter Inc.
Drugs Thyro-Tab 0.050 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA. Lot HB23111 and HC23111 Class II Subpotent; 9-month stability interval Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 50 mcg., 100-count bottles, Rx only, NDC 0456-1321-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot 1093992 and 1094095, exp. date 9/2012 Class II Subpotent; 9-month stability interval Lloyd Inc. of Iowa
Drugs Thyro-Tab 0.075 mg., packaged in 150,000-tablet bulk drums for repackaging, RX. The firm name on the label is Lloyd Pharmaceutical, Shenandoah, IA Lot HF23111 Class II Subpotent; 9-month stability interval Lloyd Inc. of Iowa
Drugs Levothroid (levothyroxine sodium tablets, USP), 75 mcg., 100-count bottles, Rx only, NDC 0456-1322-01, Manufactured for Forest Pharmaceuticals, Inc., Subsidiary of Forest Laboratories, Inc., St. Louis, MO, by Lloyd Pharmaceutical, Shenandoah, IA. Lot 1094098, exp. date 9/2012 Class II Subpotent; 9-month stability interval Lloyd Inc. of Iowa
Devices GE Giraffe and Panda T-Piece Resuscitation System labeled ***T-Piece Neonatal Patient Circuit Kit Disposable with Size 1 Mask***M1091335 QTY: 10 T-Piece Disposable Circuit, QTY: 10, M1091316 T-Piece Disposable Circuit Kit with Mask Size O; M1091365 QTY: 10 T-Piece Disposable Circuit Kit with Mask, Size 1, Lot 1981713 *** Ohmeda Medical, A Division of Datex-Ohmeda, Inc. A General Electric Company Laurel, MD 20723 USA MADE IN USA*** Provides the basic equipment required for pulmonary resuscitation of infants. 7742443, 7785387, 7860461, 7875369, 7909560, and 8145199. Class I Disposable T-Piece circuits used with resuscitation systems are unable to achieve maximum Peak Inspiratory Pressure (PIP) during the pre-use check out procedure. GE Healthcare, LLC
Biologics Plasma Frozen within 24 hours (FP24) W044112107840 Class II Blood product, which was collected from a donor in which donor suitability was not adequately determined, was distributed. LifeServe Blood Center
Devices Computed Tomography X-Ray System, Extended Brilliance Workspace (EBW), Model #728260 Philips Healthcare, Highland Heights, OH The Extended Brilliance Workspace (EBW) is a component of the Computed Tomography X-Ray System that is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. Model #728260, Serial #s, 12876, 13924, 13994, 13996, 14104, 14116, 14677, 14682, 14694, 14695, 14702, 14707, 14710, 14727, 14728, 14730, 14824, 14840, 14926, 14930, 14932, 14940, 15008, 15015, 15017, 15023, 15036, 15081, 15085, 15146, 15329, 15354, 15393, 15397, 15398, 15399, 15400, 15401, 15402, 15403, 15451, 15453, 15550, 15551, 15552, 15553, 15554, 15555, 15556, 15557, 15558, 15559, 15560, 15561, 15562, 15563, 15564, 15565, 15566, 15567, 15568, 15569, 15570, 15571, 15572, 15573, 15574, 15575, 15576, 15577, 15578, 15579, 15580, 15581, 15582, 15583, 15584, 15585, 15586, 15587, 15588, 15589, 15590, 15591, 15592, 15593, 15594, 15595, 15596, 15597, 15598, 15599, 15600, 15601, 15602, 15603, 15604, 15605, 15606, 15607, 15608, 15609, 15610, 15611, 15612, 15613, 15614, 15615, 15616, 15617, 15618, 15619, 15620, 15621, 15622, 15623, 15624, 15625, 15626, 15627, 15628, 15629, 15630, 15631, 15632, 15633, 15634, 15635, 15636, 15637, 15638, 15639, 15640, 15641, 15642, 15643, 15644, 15645, 15646, 15647, 15648, 15649, 15650, 15651, 15652, 15653, 15654, 15655, 15656, 15657, 15658, 15659, 15660, 15661, 15662, 15663, 15664, 15665, 15666, 15667, 15668, 15669, 15670, 15671, 15672, 15673, 15674, 15675, 15676, 15677, 15678, 15679, 15680, 15681, 15682, 15683, 15684, 15685, 15686, 15687, 15689, 15690, 15691, 15692, 15694, 15695, 15696, 15697, 15698, 15699, 15700, 15701, 15702, 15703, 15704, 15705, 15706, 15707, 15708, 15709, 15710, 15711, 15712, 15713, 15714, 15715, 15716, 15717, 15718, 15719, 15720, 15721, 15722, 15723, 15724, 15725, 15726, 15727, 15728, 15729, 15730, 15731, 15732, 15734, 15735, 15736, 15737, 15753, 15754, 15755, 15756, 15757, 15758, 15760, 15761, 15762, 15763, 15764, 15765, 15766, 15767, 15768, 15770, 15771, 15772, 15800, 15801, 15802, 15803, 15804, 15805, 15806, 15807, 15808, 15809, 15810, 15811, 15812, 15813, 15814, 15818, 15820, 15821, 15826, 15827, 15828, 15829, 15830, 15831, 15832, 15834, 15835 & 15900. Class II Philips is issued a Field Change Order to update Extended Brilliance Workspace (EBW) systems to software version 4.5.5. The update will provide a number of improvements to address nonhazardous reliability issues which will improve the overall quality and functionality of the EBW. Philips Medical Systems (Cleveland) Inc
Devices Stryker Howmedica Osteonics; Stryker T2 Humerus System Teflon Tube, sterile; REF 1806-0073S The T2 Nailing System is designed to treat complex fractures in Humeral, Femoral, Tibial and Ankle applications. The Teflon Tube is an optional instrument used to exchange the Ball Tip Guide Wire with the Smooth Tip Guide Wire once reaming is completed. Stryker Stryker Trauma GmbH 24232 Schonkirchen, Germany distributed in USA by: Howmedica Osteonics Corp., 235 Corporate Drive, Catalog No: 1806-0073S Lot Code:123596 Class II During the manufacturing of the affected lot a manufacturing error has led to embrittlement of the tube material of the T2 Humerus Teflon Tube. Stryker Howmedica Osteonics Corp.
Devices Brookstone Heated Body Bean, electrically heated SKU numbers: 734863 (BlNationwide Distributionue), 734864 (Plum), 734865 (Red). Brookstone 3 in 1 wrap ,SKU734397 (Brown). The Products are liquid filled bean shaped pouches that are electrically heated and then detached from the charger prior to use. All lot codes Class II Additional Warning Statement to prevent burns to the skin Brookstone Company, Inc.
Drugs Levothyroxine Sodium Tablets, USP, 175 mcg in 90 ct bottles, Manufactured by Patheon Puerto Rico Inc., for Alara Pharmaceutical Corp, San Juan, PR 11T7011A, Exp. Date: 12/2012 Class II Subpotent; 15 month stability Alara Pharmaceutical Co
Devices Access Immunoassay System, Access 2 Immunoassay System, Synchron LXi 725 Clinical System, UniCel DxC 600i Synchron Access Clinical System Part Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC 600i  A25640. The Access Immunoassay System is an in vitro diagnostic device used for the quantitative, semi-quantitative or qualitative determination of various analyte concentrations found in human body fluids. The Synchron LXi and the UniCel DxC 600i are Access systems integrated with a chemistry analyzer. Part Numbers: Access  81600; Access 2  81600N, 386220, A69186, A25656, A12900; Access 2 (LXi)  A15642; Access 2 Section, DxC 600i  A25640 Class II It has been determined that, in some cases, pulley drive components have broken parts or have become loose, mispositioned, or disconnected from their drive shafts. When these defects occur, the pulley may not turn at all, or may turn at an incorrect speed, resulting in inadequate washing or mixing of the contents of the reaction vessel. Beckman Coulter Inc.
Drugs Cymevene 500 mg Powder for Infusion, (ganciclovir), 50 mg/mL ganciclovir (reconstructed), Rx only, 10 mL vials, Roche Products Limited, Welwyn Garden City, AL7 1TW, United Kingdom bulk lot N0019, Expiration Date: 11 2014 Warennummer: 10131968 Chargennummer:NXXXX 2000609D Finished product Lot N0019B01-N0019B12 Class II Lack of Assurance of Sterility; container closure issues with the bulk batch. F. Hoffmann-LaRoche Ltd.
Food/Cosmetics Spence & Co New York-Style Nova Lox 4oz , refrigerated Spence & Co Smoked Salmon Trimmings, 2lb bulk (bag) Code: 9720704 Class I Product contaminated with Listeria monocytogenes Spence & Co., Ltd.
Devices Biosense Webster MobiCath Bi-Directional Guiding Sheath. Small Curve catalog no. D140010, Large Curve catalog no. D140011. The MobiCath Bi-Directional Guiding Sheath is a flexible tipped percutaneous catheter introducer (or guiding sheath) designed for gaining access to the coronary systems. The device features adjustable tip geometry through use of a rotating handle to deflect the catheter. This catheter is assembled with a hemostasis valve and a sideport infusion line. The MobiCath Bi-Directional Guiding Sheath is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum. LOT: R1701247 , R1713591 , W2046680 , W2046681 , W2072907 , W2078460 , W2084872 , W2098771 , W2102124 , W2102133 , W2102134 , W2108295 , W2108296 , W2108298 , W2108299 , W2125688 , W2125690 , W2132584 , W2132588 , W2132590 , W2138965 , W2143147 , W2143149 , W2143152 , W2145645 , W2145677 , W2145680 , W2145681 , W2151287 , W2151305 , W2151308 , W2156746 , W2156748 , W2156750 , W2156751 , W2162496 , W2162497 , W2162498 , W2162499 , W2167986 , W2167987 , W2167988 , W2167990 , W2172705 , W2172706 , W2172707 , W2172708 , W2172710 , W2172712 , W2177727 , W2177728 , W2177733 , W2177734 , W2184476 , W2184483 , W2184484 , W2184487 , W2190457 , W2190461 , W2190464 , W2190470 , W2196349 , W2196351 , W2196352 , W2196355 , W2196359 , W2196361 , W2196363 , W2211842 , W2211844 , W2211846 , W2211849 , W2211852 , W2211853 , W2213887 , W2229974 , W2236588. Class II Greatbatch Medical observed some anomalies of the inner lumen of the MobiCath Bi-Directional Guiding Sheaths upon implementation of a new visual inspection tool. The anomalies may include loose, string-like liner material, liner abrasion (fraying), and/or attached string-like liner material (from scratches or damage on the inner wall of sheath lumen). Greatbatch Medical
Devices Ardis Interbody System Inserter The Ardis Inserter is intended for delivery of the Ardis Implant into the cleared disc space. The implant is secured to the inserter via finger-tightening the gold and silver knobs of the inserter to thread the shaft securely to the implant. Once the implant is inserted into the disc space and its position confirmed radiographically, the inserter is removed from the implant by turning the knobs counterclockwise to loosen and unthread the shaft from the implant. Ardis Inserter, Part number: 3256-01 Lot numbers - 52ZW, 50CL, 53BB, 55AB, 580S, 580T, 60JY, 60JZ, 62KP, 63HJ, 64EY, 68AX, 71JE, and 75LE Class I The Ardis System implant may break when excessive lateral forces are applied to the implant during insertion using the Ardis Inserter. Zimmer Spine has received complaint reports at a 0.47% occurrence rate associated with this issue (data from a 54 month monitoring period). Zimmer, Inc.
Food/Cosmetics CMC Pumpkin Coffee Cake 16 oz UPC: 041735225726 Price Chopper/Box UPC # 41735-225726 expiration date between October 17 and October 25, 2012 Class I CMC Cinnamon Coffee Cake was incorrectly labeled as Pumpkin Coffee Cake and therefore did not list walnuts as an ingredient Golub Corp
Devices Praxair Vantage Grab n Go - Gas Cylinder pressure regulator Catalog Number: OX-M-AEGNGVNTG Usage: Regulator reduces pressure in oxygen-containing cylinder. OX M-AEGNGVNTG (US and Canada) and WESPRX-9500 (Global) Cyclinders in service since Jan 2009. Units with a "T" decal (T-teflon) on the fill side of the valve have the rework completed. Class I Isolated incidents of ignition inside Grab n' Go cylinders that had been knocked over or otherwise subject to significant physical impact. Praxair Inc.
Devices Diamigo i-Phone App The Diamigo app was intended for use as an educational tool in the management of diabetes. n/a Class II Diamigo, a software application, was released through the i-Phone Global Store which inadvertently allowed global access to the application as opposed to the original intended restriction of access to Brazil. sanofi-aventis US, Inc.
Devices COBAS AmpliPrep Instrument (CAP) with AMPLILINK (AL) Software v.3.3.5 Automated sample processing instrument used with CAP/CA and CAP/CTM. Roche Molecular Systems, Inc. 1080 US Highway 202 South Branchburg, NJ 08876 USA Made in Switzerland CAP 394436 to 394663 Class II Certain COBAS AmpliPrep instruments using AMPILINK software v.3.3.4 had the sample clot detection flagging feature disabled during quality control release resulting in samples that may not be flagged as having clots. Roche Molecular Systems, Inc.
Devices Flowtron Trio DVT Pump; an Rx intermittent pneumatic compression deep vein thrombosis pump; ArjoHuntleigh AB, Eslov, Sweden; Model 512003; a non-invasive prophylaxis system for reducing the incidence of deep vein thrombosis. Model 512003, all serial numbers Class II The Flowtron Trio DVT Pump has been marketed without proper FDA Approval. Arjo, Inc. dba ArjoHuntleigh
Food/Cosmetics Taylor Farms Hearts of Romaine Lettuce, All Natural, Fresh Hand Selected, Triple Washed and Ready to Enjoy. 10 oz. bags. Taylor Farms, Salinas, CA. UPC 0 30223 04032 3 Code TFRS 332A09; Best By 12-13-12 06:51 B Class I Positive IEH sample of Listeria Monocytogenes found in Taylor Farms Hearts of Romaine Taylor Farms Retail, Inc.
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