Vaccines, Blood & Biologics
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2005 Biologics Recalls
Date Notification | Brand Name | Product Description | Reason/Problem | Company |
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| 12/15/2005 | Notice of Field Correction: Haemonetics MCS+ 9000, Cell Saver 5, Cell Saver 5+-Haemonetics Corp | Haemonetics LN9000 Collection System (Model Number: LN9000-110-E) Serial Numbers: 05D056; 05F064-1; 05F065; 05G101; 05G103; 05H094 Haemonetics Cell Saver 5 Autologous Blood Recovery System (Model Number: LN02005-110-E) Serial Numbers: 94H180CD-1; 95A048CS; 95J177CS Haemonetics Cell Saver 5+ Autologous Blood Recovery System (Model Number LN02005-110EP) Serial Numbers: 05F022-1; 05F023-1; 05H103;05C083-05C084; 05C087-05C089;05D006-05D011;05D037--05D040; 05D043-05D047;05D060-05D068; 05D080--05D081; 05D085-05D089; 05E026-05E035;05E054-1; 05E055-1; 05E056;05E061-05E070; 05E091-05E095; 05F021; 05F066-05F072; 05F098-05F107;05F142-05F144; 05F147; 05F149; 05F150; 05F157-05F159;05G008-1; 05G009-05G012; 05G035-05G037; 05G038-1; 05G055-1; 05G057-05G059; 05G080-05G084;05H018; 05H022; 05H024- 05H027; 05H073-05H077; 05H100-05H101; 05H104; 05H163; 05J185-05J189; 05K011-05K013; 05K015-05K017; 05K092-05K096; 05K168-05K173 ; 05K175; 05K201 | Haemonetics has become aware that the Liquid Crystal Display (LCD) on the above listed devices may emit radiofrequency waves that exceed the level permitted by International Standards. | Haemonetics Corporation Braintree, Massachusetts |
| 11/21/2005 | Recall of Charter Medical Transfer Bags-Charter Medical, Ltd | PRODUCT / LOT NUMBER / EXPIRATION DATE: 100mL Six Bag Aliquot System with piercing pin and injection site Product Code: T2186 Lot Number: 109851 Expiration Date: March, 2009 | The labels affixed to the bags, referred to as the volunteer donor labels, state 150 mL, which is incorrect. | Charter Medical, Ltd Winston-Salem, NC |
| 11/18/2005 | Recall of LCG2 Leukoreduction System for Red Blood Cells-MacoProductions S.A.S. | PRODUCT / LOT NUMBERS / EXPIRATION DATE: MacoPharma Leucolab LCG2 Leukoreduction System for Red Blood Cells KSV0004XD Lot Numbers: 232305F14, 232305F20 Expiration Date: June, 2008 | Two lots of MacoPharma’s Leucolab LCG2 Leukoreduction System for Red Blood Cells are recalled due to potential failure to meet leukoreduction requirements. | MacoProductions S.A.S. France |
| 10/28/2005 | Recall of Baxter ALYX Red Kit Disposables-Baxter Healthcare Corp | Baxter ALYX Red Kit Disposables (Designed for the ALYX Component Collection System) 4R5701 All lot numbers starting with H04J, H04K, H04L, H05A, H05B, H05C, H05D, H05E, H05F, H05G, and H05H (except those suffixed with "A") 4R5701 H05I02028 (but NOT H05I02028A) 4R5701 H05I13041 (but NOT H05I13041A) 4R5701 H05I19071 (but NOT H05I19071A) Unaffected lots include any lot numbers labeled with an "A" suffix. | Baxter Healthcare Corporation has received reports from users of the ALYX Component Collection System of leaks from the cassette of the disposable kit. | Baxter Healthcare Corporation Round Lake, Illinois |
| 10/26/2005 | FDA Provides Information on Investigation into Human Tissue for Transplantation | Human Tissue For Transplantation | The tissue was recovered by BTS from human donors who may not have met FDA donor eligibility requirements and who may not have been properly screened for certain infectious diseases. | Biomedical Tissue Services, Ltd. (BTS) Ft. Lee, NJ |
| 10/14/2005 | Recall of Human Tissue Products-Regeneration Technologies, Inc | Human Tissue For Transplantation | Regeneration Technologies, Inc. (RTI) is conducting a voluntary recall of all tissue received from BioMedical Tissue Services (BTS; Ft. Lee, New Jersey) as a result of information regarding the accuracy of donor screening documentation. | Regeneration Technologies, Inc Alachua, Florida |
| 10/13/2005 | Recall of Human Tissue-Biomedical Tissue Services, Ltd | Human Tissue for Transplantation | Biomedical Tissue Services (BTS) was recently made aware that there is the possibility that tissue has been procured from donors without proper medical/social histories. | Biomedical Tissue Services, Ltd Fort Lee, New Jersey |
| 10/13/2005 | Medical Device Notification Transfer Set with 150 Micron Filter-Charter Medical | Transfer Set with 150 micron filter with distal slip lock patient adapter Lot Number: 110220 Catalog Number: 03-960-57 Expiration Date: June, 2009 | The product is labeled sterile. However, the devices were not subjected to ethylene oxide sterilization processing and are therefore, non-sterile. | Charter Medical, Ltd Winston-Salem, NC 27103 |
| 10/12/2005 | Recall of Human Tissue Products-Tutogen Medical, Inc | Human Tissue for Transplantation | This action is being taken because Tutogen is unable to satisfactorily confirm that donor eligibility had been properly obtained by BTS. | Tutogen Medical, Inc. Alachua, Florida |
| 10/11/2005 | Recall of Human Tissue Products-The Blood and Tissue Center of Central Texas | Human Tissue for Transplantation | Central Texas Regional Blood and Tissue Center is voluntarily recalling tissue products as the firm is unable to confirm information provided by BioMedical Tissue Services. | The Blood and Tissue Center of Central Texas Austin, Texas |
| 10/11/2005 | Recall of Plasma Protein Fraction, Plasmanate-Talecris Biotherapeutics | Plasma Protein Fraction (Human) 5% USP, Plasmanate 26N39N1 9/20/2008 | A portion of lot 26N39N1 was processed during a period of time when the equipment used to secure an overseal on the bottle was noted to have fallen out of proper adjustment. | Talecris Biotherapeutics Clayton, North Carolina |
| 10/10/2005 | Withdrawal of Human Tissue Products-Lost Mountain Tissue Bank | Human Tissue for Transplantation | LMTB was informed of some discrepant and possibly fraudulent information in donor documentation. | Lost Mountain Tissue Bank Kennesaw, Georgia |
| 9/30/2005 | Recall of Human Tissue Products-LifeCell Corp | AlloDerm, Repliform, and GraftJacket | The recall was prompted when internal quality processes raised questions about the donor documentation received from one tissue recovery organization. | LifeCell Corporation Branchburg, New Jersey |
| 8/29/2005 8/26/2005 | Recall of Albumin (Human) 25 %, Albuminar (Updated)-ZLB Behring LLC | Albumin (Human) 25%, Albuminar, 100 mL U.S. Distribution: C934009 9/16/2007 C934110 10/5/2007 C805209 8/31/2007 (China) C805309 9/24/2007 (China) C934210 10/7/2007 (Japan) C934310 10/14/2007 (Japan) | One bottle of Albuminar in Japan has been found with a stopper defect that may allow product leakage. The same stopper batch as that used in Japan was also used on these lots. | ZLB Behring L.L.C. King of Prussia, PA |
| 8/29/2005 | Recall of Albumin (Human) 25 %, Albuminar, ZLB Behring LLC | Albumin (Human) 25%, Albuminar, 100 mL C934009 9/16/2007 C934110 10/5/2007 | One bottle of Albuminar in Japan has been found with a stopper defect that may allow product leakage. The same stopper batch as that used in Japan was also used on these two lots. | ZLB Behring L.L.C. King of Prussia, PA |
| 8/2/2005 | Medical Device Notification: Hotline L-10 Gas Vent-Smiths Medical ASD, Inc | HOTLINE L-10 Gas Vent (used on Hotline and Hotline 2 fluid warming devices) Lot Numbers: 200505WM, 200506AM, 200506MM, 200506PM, 200506RM, 200506UM, 200506YM | Smiths Medical issued an “Important: Advisory Notice” to notify consignees of a labeling error concerning the L-10 Gas Vent. | >Smiths Medical ASD, Inc. Rockland, MA |
| 6/20/2005 | Recall of Level 1 H-31B Air Detector/Clamping Devices, Level 1 H-1200 Fast Flow Fluid Warmers-Smiths Medical ASD, Inc | Level 1 H-31B Air Detector / Clamping Devices Level 1 H-1200 Fast Flow Fluid Warmers (with integrated H-31B Air Detector/Clamp) | The Air Detector’s clamping mechanism may not close completely on the IV administration set and/or may have sensitive door/tubing secondary alarm interlocks. | Smiths Medical ASD, Inc. Rockland, MA |
| 6/20/2005 6/10/2005 | Medical Device Notification: 150mL Eight Bag Aliquot System with Piercing Pin and Needleless Syringe Adaptor-Charter Medical, Ltd. | 150mL Eight Bag Aliquot System with Piercing Pin and Needleless Syringe Adaptor Lot Number: 108779 Catalog Number: T2288 | The product label is missing relevant information including sterilization method, expiration date, "Rx only" symbol and the "Do Not Reuse" symbol. | Charter Medical, Ltd. Winston-Salem, North Carolina |
| 6/14/2005 | Recall of Hemoflow Model 300-Applied Science, Inc | Hemoflow Model 300 Product Code 9-3000-0xxx Serial Numbers: B4162 thru B4167; B4225 thru B4314, and B4315 thru B4324 | Hemoflow Model 300 mixer may fail to start at the beginning of a draw due to a mismatch between motor characteristics and driver circuitry. | Applied Science, Inc Grass Valley, CA |
| 5/20/2005 | Medical Device Notification: Misys Laboratory Blood Bank and Blood Donor, Version 6.1-Misys Healthcare System | Misys Laboratory Blood Bank and Blood Donor, Version 6.1 | Information entered into the comment field may be lost when resulting the blood type for the first time via a blood bank instrument interface. | Misys Healthcare System Tuscon, AZ |
| 5/17/2005 | Urgent Product Correction: Six-Part BarCode Labels for Sarstedt Tubes-Roche Diagnostics Corporation, Inc. | Six-Part BarCode Labels for Sarstedt Tubes For Use with COBAS AmpliScreen System | Roche Diagnostics has confirmed complaints received from four customers that rolls of six-part barcode labels, Roche M/N 03261549001, Batch Nos. 028868 and 029213, may contain duplicate barcode numbers. | Roche Diagnostics Corporation, Inc. Indianapolis, Indiana |
| 3/30/2005 | Recall of Platelet Sampling Device-Charter Medical Ltd | Platelet Sampling Device Product Numbers: 03-220-AC, 03-220-BC, 03-220-LKY, 03-220-TMR | The sterility of these devices may be compromised due to an inadequate validation of the sterilization cycle. | Charter Medical, Ltd Winston-Salem, NC |
| 3/16/2005 | Recall of CPDA-1 Quadruple Blood-Pack Unit, Baxter Blood-Pack Unit (BPU) with Samplink Access Device-Baxter Healthcare Corp | Blood-Pack Unit with Samplink Access Device Product Code 4R1247MC Serial Number Expiration Date M02I26046 3/31/2005 M02I26046A 3/31/2005 M02J10064 4/30/2005 M02J10064A 4/30/2005 M02K18032 5/31/2005 M02K30029 5/31/2005 M03A31067 7/31/2005 M03B14038 8/31/2005 M03B14038A 8/31/2005 M03B28053 8/31/2005 M03C21056 9/30/2005 M03E28056 11/30/2005 M03K06051 5/31/2006 M04A17032 7/31/2006 M04C26039 9/30/2006 M04E07034 11/30/2006 | Baxter has determined that expired Samplink access devices were included in cases of Blood-Pack Unit, Product Code Number 4R1247MC (the Blood-Pack Units were not expired). | Baxter Healthcare Corporation Round Lake, Illinois
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| 3/16/2005 | Device Correction of Baxter Amicus Separator-Baxter Healthcare Corp | AMICUS SEPARATOR Product Codes 4R4580 and 4R4580R All Serial Numbers | Baxter has redesigned the AMICUS SEPARATOR Instrument centrifuge window to withstand ammonia cleaning; however it is Baxter's recommendation that ammonia and ammonia based cleaners NOT be used to clean any part of the AMICUS SEPARATOR Instrument. | Baxter Healthcare Corporation Deerfield, Illinois |
| 3/15/2005 | Recall of Sepacell PLS-5A Platelet Leukoreduction Filter with Administration Set, Platelet Bedside Filter-Baxter Healthcare Corp | Platelet Bedside Filter Product Code Number - 4C2496 Lot Number - A04I08265 | Baxter has determined that the pre-filter on Platelet Bedside Filter sets were assembled in the inverted orientation. | Baxter Healthcare Corporation Deerfield, Illinois |
| 2/25/2005 | Medical Device Notification: HNA Classic 306 Patient Manager Blood Bank Software-Cerner Corp | HNA Classic 306 Patient Manager - Revision 159 and higher | The patient's antibodies may be removed from the Blood Bank record or the Blood Bank record may be removed entirely from the Cerner system. | Cerner Corp Kansas City, MO |
| 2/25/2005 | Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection System-Haemonetics Corp | Automated Blood Cell Separator, Haemonetics LN8150 Mobile Collection System, MCS+ 9000 Model Number: LN 08150-110-E Serial Numbers: 05A047-05A048, 05A050, 05A064-05A072, 05A092-05A100, 05B017-05B023 | Haemonetics has discovered a manufacturing error on the MCS+ LN8150 CPU board that could affect display performance and result in inability to initiate a procedure or premature termination of a procedure. | Haemonetics Corp Braintree, MA |
| 2/24/2005 | Medical Device Notification: StemCXP Software, Version 1.0-Beckman Coulter, Inc | StemCXP Software Version 1.0 for Cytomics FC 500 Part Number - 628843 | Beckman Coulter issued an "Urgent: Product Corrective Action" Notification relating to two issues with stemCXP Software. | Beckman Coulter, Inc Brea, CA |
| 2/23/2005 | Recall of Additional Lot of Leukocyte Reduction BPF4 High Efficiency Filter-Pall Medical Corp | Product Code 430-50 0450737 | Pall Medical has received additional reports of hemolysis in the attached segment tubing and the storage bags observed at varying times during filtration using this product. | Pall Medical Corporation 2200 Northern Blvd East Hills, NY 11548 |
| 2/23/2005 | 12/17/2004 Recall Notice | Product Code 430-41 0450481 0450520 0450560 0450583 0450613 0450630 0450650 0450672 0450673 0450674 0450684 0450685 0450690 0450707 0450708 0450712 0490006 Product Code 430-50 0450574 0450626 0450661 0450665 0450668 0450710 0450714 Product Code BPFB 0450615 | Pall Medical has received reports of hemolysis in the attached segment tubing and the storage bags observed at varying times following filtration using this product. | Pall Medical Corporation 2200 Northern Blvd East Hills, NY 11548 |
| 2/18/2005 | Notice of Field Correction: Sorvall Cellwasher 2, Cell Washing System-Kendro Laboratory Products | Sorvall Cellwasher 2 containing a (DA-12 rotor arm assembly) Model Number: 04500 Serial Numbers: R28O-155736-SO S11O-155794-SO S11O-155795-SO S17O-155835-SO S24O-155869-SO S24O-155870-SO T07O-155911-TO T14O-155953-TO T14O-155954-TO U12O-156092-UO U19O-156114-UO U19O-156115-UO U26O-156156-UO U26O-156157-UO V03O-156216-VO V03O-156218-VO V09O-156247-VO V09O-156253-VO V09O-156254-VO V09O-156261-VO V09O-156262-VO V09O-156263-VO V09O-156264-VO V09O-156265-VO V09O-156266-VO V16O-156330-VO W140-156453-WO W14O-156447-WO W14O-156451-WO W23O-156496-WO W23O-156506-WO X14N-109222-XN | The DA-12 rotor arm assembly problem prevents one or more tube holders (part number 04102) from returning to their full vertical position after completing either a high speed or low speed centrifuge run, or after completing a wash cycle. | Kendro Laboratory Products Asheville, NC |
| 2/18/2005 | Important Product Information - Correction - Corzyme-Abbott Laboratories | List Number 9977 All Lots | The results of the study revealed differences in PEI Units/mL of the anti-HBc dilution panel as compared to a reference serum from the Paul Erhlich-Institut. As a result of this difference, concentrations expressed in PEI Units/mL are inaccurate. | Abbott Laboratories Abbott Park, IL |
| 2/7/2005 | FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media - Talkpaper | Rapid HIV Test Kit Rapid Syphilis Test Kit One Step Cassette Style Cocaine Test One Step Cassette Style Marijuana (THC) Test One Step Cassette Style Amphetamine Test Rapid Dengue Fever Test One Step Midstream Style HCG Urine (Home) Pregnancy Test | This talk paper was originally issued Feb. 7, 2005, and was revised Feb. 11, 2005, to clarify that, whereas no home-use diagnostic kits marketed by Globus Media are approved by FDA, one HIV home collection test system made by a different manufacturer has FDA approval. | Globus Media, Inc Montreal, Canada |
| 2/4/2005 | Recall of Rapid HIV Test Kits-Globus Media, Inc | Rapid HIV Test Kit | Rapid HIV Test Kits, marketed nationwide via the Internet, by Globus Media, were not reviewed for safety and effectiveness as required under U.S. law. | Globus Media, Inc Montreal, Canada |
| Unapproved Home-Use Diagnostic Kits Marketed by Globus Media-Medwatch | home-use diagnostic test kits | No home-use test kits intended for diagnosing HIV, syphilis and dengue fever are approved for sale in the U.S. | Globus Media, Inc Montreal, Canada | |
| 1/31/2005 | Recall of Amicus Apheresis Kits-Baxter Healthcare Corporation | PRODUCT / LOT NUMBER / EXPIRATION DATE: Product Code 4R2310N04D22010 April 2005 N04F14012 June 2005 N04F15019 June 2005 N04F16017 June 2005 N04F21017 June 2005 N04F22015 June 2005 N04F24011 June 2005 N04F28012 June 2005 N04F29010 June 2005 N04F30018 June 2005 N04G22013 July 2005 N04G23011 July 2005 N04G02023 July 2005 N04G12014 July 2005 N04G13012 July 2005 N04G14010 July 2005 N04G15017 July 2005 N04G16015 July 2005 N04G30016 July 2005 N04H16013 Aug 2005 N04H10016 Aug 2005 PRODUCT / LOT NUMBER / EXPIRATION DATE: Product Code 4R2312 N04E27024 May 2005 N04F18013 June 2005 N04F25018 June 2005 N04G01017 July 2005 N04G20017 July 2005 N04G20025 July 2005 N04G06016 July 2005 N04G07014 July 2005 N04G08012 July 2005 N04G09010 July 2005 N04G10018 July 2005 N04G19019 July 2005 | Pinhole leaks were observed at the two-omega end of the umbilicus (multilumen tubing), causing a blood leak. | Baxter Healthcare Corporation Deerfield, IL |
| 1/25/2005 | Recall of Blood Bank Devices-Charter Medical, Ltd. | LOT NUMBER / Expiration Date ALS843-2 9/16/2005 | Gamma has identified microbial contamination in some bottles of Alsever's Solution. | Gamma Biologicals, Inc Houston, Texas |
| 1/18/2005 | Market Withdrawal of HIV-1 / HCV Assay-Procleix - Gen-Probe Inc | HIV-1 / HCV Assay, Procleix Lot Number: 401254 1000 Test Kit - Part Number 301031 5000 Test Kit - Part Number 301030 | Procleix HIV-1 / HCV Assay, Master Lot 401254, was found to contain an elevated level of copper. | Gen-Probe Inc San Diego, CA |
| 1/8/2005 | Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical Diagnostics | Product Code 780540, Lots FS451, FS452, and / or FS453 | It is possible that this test did not identify some patients who experienced fetal-maternal hemorrhage (FMH) of greater than 30 mL whole blood (15 mL packed cells) as candidates for treatment with more than the usual post-partum Rh Immune Globulin (RhIG) dose of 300 µg. | Ortho-Clinical Diagnostics |
| 1/8/2005 | Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical Diagnostics | PRODUCT / LOT NUMBER / EXPIRATION DATE: FETALSCREEN (Product Code 780540) FS451 12/21/2004 FS452 1/18/2005 FS453 2/15/2005 | Ortho-Clinical Diagnostics, Inc. (OCD) has received reports of weak or negative reactivity with the positive control provided in these kits. | Ortho-Clinical Diagnostics Raritan, NJ |
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