Vaccines, Blood & Biologics

2005 Biologics Recalls

Date
Notification
Brand NameProduct DescriptionReason/ProblemCompany
12/15/2005Notice of Field Correction: Haemonetics MCS+ 9000, Cell Saver 5, Cell Saver 5+-Haemonetics CorpHaemonetics 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
11/21/2005Recall of Charter Medical Transfer Bags-Charter Medical, LtdPRODUCT / 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
11/18/2005Recall 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
10/28/2005Recall of Baxter ALYX Red Kit Disposables-Baxter Healthcare CorpBaxter 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
10/26/2005FDA Provides Information on Investigation into Human Tissue for TransplantationHuman Tissue For TransplantationThe 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
10/14/2005Recall of Human Tissue Products-Regeneration Technologies, IncHuman Tissue For TransplantationRegeneration 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
10/13/2005Recall of Human Tissue-Biomedical Tissue Services, LtdHuman Tissue for TransplantationBiomedical 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
10/13/2005Medical Device Notification Transfer Set with 150 Micron Filter-Charter MedicalTransfer 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
10/12/2005Recall of Human Tissue Products-Tutogen Medical, IncHuman Tissue for TransplantationThis 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
10/11/2005Recall of Human Tissue Products-The Blood and Tissue Center of Central TexasHuman Tissue for TransplantationCentral 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
10/11/2005Recall of Plasma Protein Fraction, Plasmanate-Talecris BiotherapeuticsPlasma 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
10/10/2005Withdrawal of Human Tissue Products-Lost Mountain Tissue BankHuman Tissue for TransplantationLMTB was informed of some discrepant and possibly fraudulent information in donor documentation.Lost Mountain Tissue Bank
Kennesaw, Georgia
9/30/2005Recall of Human Tissue Products-LifeCell CorpAlloDerm, Repliform, and GraftJacketThe 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 LLCAlbumin (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
8/29/2005Recall of Albumin (Human) 25 %, Albuminar, ZLB Behring LLCAlbumin (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
8/2/2005Medical Device Notification: Hotline L-10 Gas Vent-Smiths Medical ASD, IncHOTLINE 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
6/20/2005Recall of Level 1 H-31B Air Detector/Clamping Devices, Level 1 H-1200 Fast Flow Fluid Warmers-Smiths Medical ASD, IncLevel 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
6/14/2005Recall of Hemoflow Model 300-Applied Science, IncHemoflow 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
5/20/2005Medical Device Notification: Misys Laboratory Blood Bank and Blood Donor, Version 6.1-Misys Healthcare SystemMisys Laboratory Blood Bank and Blood Donor, Version 6.1Information 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
5/17/2005Urgent 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
3/30/2005Recall of Platelet Sampling Device-Charter Medical LtdPlatelet 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
3/16/2005Recall of CPDA-1 Quadruple Blood-Pack Unit, Baxter Blood-Pack Unit (BPU) with Samplink Access Device-Baxter Healthcare CorpBlood-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
3/16/2005Device Correction of Baxter Amicus Separator-Baxter Healthcare CorpAMICUS 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
3/15/2005Recall of Sepacell PLS-5A Platelet Leukoreduction Filter with Administration Set, Platelet Bedside Filter-Baxter Healthcare CorpPlatelet 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
2/25/2005Medical Device Notification: HNA Classic 306 Patient Manager Blood Bank Software-Cerner CorpHNA Classic 306 Patient Manager - Revision 159 and higherThe 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
2/25/2005Notice of Field Correction: Automated Blood Cell Separator, Haemonetics Mobile Collection System-Haemonetics CorpAutomated 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
2/24/2005Medical Device Notification: StemCXP Software, Version 1.0-Beckman Coulter, IncStemCXP 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
2/23/2005Recall of Additional Lot of Leukocyte Reduction BPF4 High Efficiency Filter-Pall Medical CorpProduct 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
2/23/200512/17/2004 Recall NoticeProduct 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
2/18/2005Notice of Field Correction: Sorvall Cellwasher 2, Cell Washing System-Kendro Laboratory ProductsSorvall 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
2/18/2005Important Product Information - Correction - Corzyme-Abbott LaboratoriesList 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
2/7/2005FDA Warns Consumers Not to Use Home-Use Diagnostic Kits Marketed by Globus Media - TalkpaperRapid 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
2/4/2005Recall of Rapid HIV Test Kits-Globus Media, IncRapid HIV Test KitRapid 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-Medwatchhome-use diagnostic test kitsNo 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
1/31/2005Recall of Amicus Apheresis Kits-Baxter Healthcare CorporationPRODUCT / 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
1/25/2005Recall 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
1/18/2005Market Withdrawal of HIV-1 / HCV Assay-Procleix - Gen-Probe IncHIV-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
1/8/2005Important Information Relating to Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical DiagnosticsProduct Code 780540, Lots FS451, FS452, and / or FS453It 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
1/8/2005Recall of Fetal Cell Screening Kit (FETALSCREEN) - Ortho-Clinical DiagnosticsPRODUCT / 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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