Vaccines, Blood & Biologics

2007 Biologics Recalls

Date
Notification
Brand NameProduct DescriptionReason/ProblemCompany
12/24/2007Market Withdrawal of Octagam-Octapharma USA Inc.Octagam [Immune Globulin Intravenous (Human) 5%]
Lot Number: A732B8431
Expiration Date: August 2009
Octapharma is taking this voluntary action based on several reports related to non life-threatening allergic type skin reactions in connection with this lot.Octapharma USA Inc.
Vienna, Austria
12/14/2007Medical Device Notification: Sunquest Laboratory Blood Bank Module - Sunquest Information Systems, IncSunquest Laboratory Blood Bank Module v6.0.1 and v6.0.2
Distributed with Sunquest Laboratory v6.1, v6.2 and v6.3
The system does not trigger all Quality Assurance warnings/failures when there is a mismatch between the reaction results and the interpretation.Sunquest Information Systems, Inc.
Tucson, Arizona
12/11/2007Recall of PedvaxHIB [Haemophilus b Conjugate Vaccine (Meningococcal Protein Conjugate)] and COMVAX [Haemophilus b Conjugate (Meningococcal Protein Conjugate) and Hepatitis B (Recombinant) Vaccine]-Merck & Co., Inc.PRODUCT DESCRIPTION/LOT#/EXP. DATE
PedvaxHIB®/0677U 11/January 2010
PedvaxHIB®/0820U 12/January 2010
PedvaxHIB®/0995U 16/January 2010
PedvaxHIB®/1164U 18/January 2010
PedvaxHIB®/0259U 17/October 2009
PedvaxHIB®/0435U 18/October 2009
PedvaxHIB®/0436U 19/October 2009
PedvaxHIB®/0437U 19/October 2009
PedvaxHIB®/0819U 09/January 2010
PedvaxHIB®/1167U 10/January 2010
PedvaxHIB®/J2438 24/October 2009
COMVAX®/0376U 05/January 2010
COMVAX®/0377U 08/January 2010
These lots of PedvaxHIB and COMVAX are being recalled due to lack of assurance of product sterility.Merck & Co., Inc.
West Point, PA
11/26/2007Recall of Tubing Sets used with COBE Spectra Apheresis System, Trima and Trima Accel Automated Blood Collection Systems-Gambro BCT, Inc.COBE Spectra Disposable Tubing Sets
Catalog Number/Tubing Set Name/Lot Number
000777110/Dual-Needle Extended Life Platelet Set with LRS Chamber/03N0005;04NXXXXX; 05NXXXXX; 06NXXXXX; 07N15247
70100/Dual-Needle Extended Life Platelet Set/04NXXXXX; 05NXXXXX; 07N15244
70300/Dual-Needle Extended Life Platelet Set with LRS Chamber/03N0006; 04NXXXXX; 05NXXXXX; 06NXXXXX; 07N15246
70310/Dual-Needle Extended Life Platelet Set with LRS Chamber/04NXXXXX; 05NXXXXX; 06NXXXXX;
70400/Single-Needle Extended Life Platelet Set with LRS Chamber/04NXXXXX; 05NXXXXX; 07N15228
777003005/Dual- Needle Extended Life Platelet Set/04NXXXXX; 05NXXXXX
777003015/Dual-Needle Extended Life Platelet Set with LRS Chamber/03N15290; 04NXXXXX; 05NXXXXX; 06NXXXXX; 07N15245; 07N15306
777003215/Single-Needle Extended Life Platelet Set with LRS Chamber/03N15288; 03N15289; 04NXXXXX; 05NXXXXX; 06NXXXXX; 07N15216

Trima Automated Blood Collection Disposable Tubing Sets
Catalog Number/Tubing Set Name/Lot Number
777800100/Trima LRS Platelet, Plasma, RBC Set with Sharps Protection/03N1130; 04NXXXX; 05NXXXX; 06NXXXX; 07N1105
777800400/Trima Accel LRS Platelet, Plasma, RBC Set/03N1116; 03N1121; 03N1126; 03N2116; 03N3116; 03N3120; 03N3126; 03N3230; 04NXXXX; 05NXXXX; 06NXXXX; 07N1118; 07N2105; 07N2113; 07N2116; 07N2203; 07N2224; 07N3102; 07N3112; 07N3117; 07N3119; 07N3124; 07N3126; 07N3131; 07N3226; 07N3230
77800401/Trima Accel LRS Platelet, Plasma, RBC Set/04NXXXX; 05NXXXX; 06NXXXX; 07N9101; 07N9102; 08N9101
777800403/Trima Accel LRS Platelet, Plasma, RBC Set/03N3128; 04NXXXX; 05NXXXX; 06NXXXX; 07N3116
777800450/Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set/04NXXXX; 005NXXXX; 06NXXXX; 07N3105;
777800451/Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set/07N9104
777800453/Trima Accel LRS Platelet, Plasma, RBC + TLR Filter Set/03N3130; 04NXXXX; 05NXXXX; 07N3213
80300/Trima Accel LRS Platelet, Plasma Set/03N0002; 03N1003; 03N1004; 03N2123; 04NXXXX; 05NXXXX; 06NXXXX; 07N2110; 07N2112; 07N2124
80400/Trima Accel LRS Platelet, Plasma, RBC Set/03N2129; 03N3124; 04NXXXX; 05NXXXX; 06NXXXX; 07N3111; 07N3118; 07N3123
80410/Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set/05NXXX; 06NXXX
80411/Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set/06NXXXX
80413/Trima Accel LRS Platelet, Plasma, RBC + Auto P.A.S. Set/05NXXXX; 06NXXXX
80420/Trima Accel Enhanced Platelet, Plasma, RBC + Auto P.A.S. Set/05NXXXX
80440/Trima Accel Enhanced Platelet, Plasma, RBC Set/04NXXXX; 06NXXXX; 07N2219; 07N3109; 07N3205
80449/Trima Accel Enhanced Platelet, Plasma, RBC Set/03N2119; 03N2121; 03N2122; 03N2127; 03N2128; 03N2226; 04NXXXX; 05NXXXX; 06NXXXX; 07N1111; 07N1116; 07N1123; 07N2126;
80450/Trima Accel LRS Platelet, Plasma RBC + TLR Filter Set/03N3121; 05NXXXX; 07N3313
80460/Trima Accel PPC, Plasma, RBC + TLR Filter Set/04NXXXX; 06NXXXX
80480/Trima Accel LRS Platelet, Plasma, RBC + TLR Filter + Auto P.A.S. Set/05NXXXX
80483/Trima Accel LRS Platelet, Plasma, RBC + TLR Filter+ Auto P.A.S. Set/05NXXXX
80490/Trima Accel Enhanced PPC, Plasma, RBC Set/03N3123; 04NXXXX; 06NXXXX; 07N3113
80491/Trima Accel Enhanced PPC, Plasma, RBC Set/03N9102; 04NXXXX; 06NXXXX; 07N9103
 

Gambro BCT is receiving a number of reports of a leak occurring near the spike port on the secondary platelet collect bag on COBE Spectra and Trima tubing sets. The secondary platelet bag does not have the Platelet Product Sampler (sample bulb).Gambro BCT, Inc.
Lakewood, CO
10/30/2007Important Notification: Blood Grouping Reagent Anti-Lea BioClone 2.0-Ortho Clinical Diagnotics, Inc.Blood Grouping Reagent Anti Lea BioClone 2.0
Product Code 715280 Lot Number/Product Code 6901859 Lot Number/ Expiration Date

LAB129A/LAB129AX/3/10/2008
LAB130A/LAB130AX/6/29/2008
LAB131A/LAB131AX/12/27/2008

OCD has received complaints of weakened reactivity or false negative reactions when using the referenced lots.Ortho Clinical Diagnostics, Inc. (OCD)
Raritan, New Jersey
10/29/2007Recall of CROFAB (Crotalidae Polyvalent Immune Fab (Ovine)-ProthericsCROFAB - Crotalidae Polyvalent Immune FAB (Ovine) / 200623 / May 2008The recall of CroFab has been initiated due to sub-potency of this lot of product at the 24 month stability point.Protherics
Wales, United Kingdom
9/19/2007Medical Device Notification: Data Innovations Instrument Manager-Data Innovations, Inc.Data Innovations Instrument Manager - Software versions 7.04.0001 through 8.04.03.01Corrupt database indices in the Specimen Management database could cause the misassociation of test and test result for a specific specimen(s).Data Innovations, Inc.
South Burlington, Vermont
8/1/2007Medical Device Notification: TERUFLEX CPDA-1 Blood Bag System-Terumo Medical CorporationTERUFLEX Blood Bags with Blood Sampling Arm
CPDA-1 Anticoagulant
450 mL Collection Bag; Triple Blood Bag

PRODUCT CODE: 1BB*TCD456A4
LOT NUMBER: 070418GV

Terumo has initiated a voluntary removal of the TERUFLEX CPDA-1 Blood Bag System because of a noted labeling discrepancy with this product.Terumo Medical Corporation
7/24/2007Field Correction of Transfer Sets Packed with Humate-P - CSL Behring LLCTransfer sets packed together with Humate-P (STN# 103960)CSL Behring has identified that blisters of the blue transfer set, which is provided with Humate-P (STN #103960) may have small holes and the transfer set should not be used anymore.CSL Behring LLC
King of Prussia, PA
7/23/2007Recall of Level 1 Normothermic IV Fluid Administration and Irrigation Sets-Smiths Medical ASD, Inc.REF Codes: D-50, D-60HL, D-70, D-100, D-300, IR-40, IR-500, IR-600, IR-700
All products with an expiration date on or before July 2011
Smiths Medical has become aware that some heat exchangers in the sets may have a leakage of the inner lumen which may allow the heating fluid to enter the patient fluid path or vice versa, which can cause contamination of the blood or solutions being infused or the recirculating solution.Smiths Medical ASD, Inc.
Rockland, MA
7/21/2007Recall of CS3000 Apheresis Kits-Fenwal, Inc.CS 3000 Apheresis Kits (All lot numbers starting with "N")
Product Codes: 4R2180T, 4R2210T
International Distribution: R4R2210T, R4R2230T
Fenwal has become aware of two instances where the anticoagulant citrate dextrose (ACD) and saline lines were reversed in the assembly process.Fenwal, Inc.
Round Lake, IL
6/12/2007Recall of m2000sp and m1000 Instrument-TECAN Schweiz AG / Abbott Molecular, Inc.m2000sp Instrument and m1000 Instrument
List Numbers 9K14-01 and 4J72-01
Not Serial Number Specific)
Abbott has recently identified that spring clips on the Disposable Tips (DiTi) Racks, shipped with or ordered independent of m2000sp or m1000 Instruments, may have sharp protruding corners.TECAN Schweiz AG
Switzerland
4/13/2007Recall of Bean, String Green Allergenic Extract-Alk AbelloBean, String Green Allergenic Extract, Vial (5)
Lot Number: 5L01102
Recent tests show that the pH of the product lot exceeded the lower specification limit of pH 6.3.Alk Abello
Port Washington, New York
3/9/2007Market Withdrawal of LAL Reagent - Associate of Cape CodPyrotell Multitest
Catalog Number: G2006 Lot Number: 206-09-395 Expiration Date: 07 Sep 2011
Catalog Number: G5006 Lot Number: 506-09-396 Expiration Date; 11 Sep 2011
This product was released with a labeled sensitivity of 0.06 EU/mL. Some samples recently tested from this lot have shown a change in sensitivity.Associate of Cape Cod
East Falmouth, MA
3/5/2007Recall of Medical Devices - Biomet Biologics, Inc800-0503A/GPS Mini Platelet Concentrate Separation Kit with 30mL ACD-A
800-0504A/GPS Mini Platelet Concentrate Separation Kit with 50ML ACD-A
800-0515/Plasmax Plus Plasma Concentrator with GPS II and 50ML ACD-A
800-1001A/GPS II Platelet Concentrate Separation Kit 50mL ACD-A
800-1002A/GPS II Platelet Concentrate Separation Kit 50mL ACD-A Double
800-0501/Plasma Plasma Concentrator with GPS Mini and 50mL ACD-A

International Distribution Only:
800-0621A/GPS II Double Unit with Syringes 30mL ACD-A
800-0650/Recover Mini Platelet Separation Kit 30mL ACD-A
800-0721A/GPS II Single Unit with Syringes 30mL ACD-A
800-0921/GPS II Single Unit with Syringes
This action was initiated due to the unit label on a limited number of syringes was incorrect, citing 20mL size.Biomet Biologics, Inc.
Warsaw, Indiana
2/22/2007Important Notification: Fast Flow Fluid Warmers-Smiths MedicalLevel 1 H-1200 with H-30 and/or H-31B Fast Flow Fluid Warmer Users
Level 1 H-30, H-31A and/or H-31B Air Detector Clamp Users
The Quick Reference Guides include an additional warning that the Air Detector/Clamp is deactivated with the unit is turned off, when power is otherwise lost to the device.Smiths Medical
Rockland, MA
2/21/2007Biological Product Withdrawal of Carimune NF Immune Globulin Intravenous-ZLB BehringCarimune® NF Immune Globulin Intravenous
Lot Number: 43017-0016
Expiration: 11/26/2009
During routine inspection of undistributed lots, ZLB identified vials with glass particles.ZLB Behring
Bern, Switzerland
1/9/2007Recall of FETALSCREEN - Ortho-Clinical DiagnosticsFETALSCREEN Product Code 780540
Lot FS472 (expiration date: January 16, 2007)
Lot FS473 (expiration date: February 13, 2007)
Ortho-Clinical Diagnostics has received reports of weak or negative reactivity with the positive control provided in FETALSCREEN lots FS472 and FS473.Ortho-Clinical Diagnostics
Raritan, New Jersey

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