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Product Description
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Recall Class
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FDA Recall Posting Date
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Recalling Firm
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MULTIGENT Acetaminophen, List Number 2K99-20
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2
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09/18/2007
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Abbott Laboratories Inc.
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Abbott i-STAT PT/INR cartridges Abbott Point of Care Inc., Princeton, NJ 08540
The i-Stat PT a pr...
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2
|
12/04/2013
|
Abbott Point Of Care Inc.
|
I-STAT EG7+ Cartridge Abbott Point of Care, Princeton, NJ.
The i-Stat EG7 cartridge is intended t...
|
2
|
08/02/2012
|
Abbott Point Of Care Inc.
|
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
|
2
|
07/09/2012
|
Abbott Point Of Care Inc.
|
Military Kit Portable Clinical Analyzer ; Abbott Point of Care, Princeton, NJ 08540
Model 200. T...
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2
|
07/09/2012
|
Abbott Point Of Care Inc.
|
i-STAT1 Abaxis Analyzer; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests...
|
2
|
07/09/2012
|
Abbott Point Of Care Inc.
|
Fuso Analyzer 300F; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for ...
|
2
|
07/09/2012
|
Abbott Point Of Care Inc.
|
i-Stat Portable Clinical Analyzer; Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 de...
|
2
|
07/09/2012
|
Abbott Point Of Care Inc.
|
iStat1 Analyzer
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree tests for sod...
|
2
|
07/09/2012
|
Abbott Point Of Care Inc.
|
i-STAT G3+ Cartridge: PCO2
Abbott Point of Care,
Princeton, NJ 08540
The test for PCO2, as part...
|
2
|
03/10/2011
|
Abbott Point Of Care Inc.
|
Military Kit i-STAT1;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 degree...
|
2
|
12/10/2010
|
Abbott Point Of Care Inc.
|
i-STAT Portable Clinical Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 deg...
|
2
|
12/10/2010
|
Abbott Point Of Care Inc.
|
Military Kit Portable Clinical Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The...
|
2
|
12/10/2010
|
Abbott Point Of Care Inc.
|
i-STAT1 Abaxis Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. The 37 degree 37 deg...
|
2
|
12/10/2010
|
Abbott Point Of Care Inc.
|
FUSO Analyzer 300F
Abbott Point of Care, Princeton, NJ 08540
Model 200. the 37 degree 37 degree C...
|
2
|
12/10/2010
|
Abbott Point Of Care Inc.
|
i-STAT Analyzer;
Abbott Point of Care, Princeton, NJ 08540
Model 200. the 37 degree 37 degree C te...
|
2
|
12/10/2010
|
Abbott Point Of Care Inc.
|
i-STAT CREA Cartridge, Abbott List Number: 06F10-01, 02; IVD. Manufactured by Abbott Point of Care, ...
|
2
|
11/24/2010
|
Abbott Point of Care Inc.
|
i-STAT BNP cartridge
Abbott Point of Care,
Princeton, NJ 08540
|
2
|
11/03/2010
|
Abbott Point Of Care Inc.
|
i-STAT CK-MB cartridge
Abbott Point of Care,
Princeton, NJ 08540
|
2
|
11/03/2010
|
Abbott Point Of Care Inc.
|
i-STAT cTnl cartridge
Abbott Point of Care,
Princeton, NJ 08540
|
2
|
11/03/2010
|
Abbott Point Of Care Inc.
|
i-STAT PT/INR Cartridge
Abbott Point of Care, Princeton, NJ
|
2
|
07/13/2010
|
Abbott Point of Care Inc.
|
Strep A Rapid Test Cassette (K031784), IST-502 Cassettes.
Brand Name (Catalog Number): Acceava St...
|
2
|
02/22/2012
|
Alere San Diego
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Strep A Twist Rapid Test Cassette (K023766), IST-502T Twist Cassettes.
Brand Name (Catalog Number...
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2
|
02/22/2012
|
Alere San Diego
|
Triage TOX Drug Screen (MTD) Panel, Model # 94400.
Type of Packaging: 25 individually pouched devic...
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2
|
04/20/2012
|
Alere San Diego dba Biosite Innovacon Hemosense Inc
|
INRatio 2 Monitors
- 0200431 Alere INRatio 2 PT/INR Professional Testing System
- 0200432 Alere IN...
|
1
|
01/03/2015
|
Alere San Diego, Inc.
|
INRatio Monitors
- 0100004 Alere INRatio PT/INR System Professional
- 0100007 INRatio Prothrombin ...
|
1
|
01/03/2015
|
Alere San Diego, Inc.
|
Product Brand Name(s): Alere Triage® TOX+MTD Drug Screen, Catalog Number 94400, Lots W56013B and W56...
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2
|
03/17/2014
|
Alere San Diego, Inc.
|
Triage TOX Drug Screen Panel, Model# 94400.
Product Usage:
The Triage TOX Drug Screen is a flu...
|
2
|
10/10/2012
|
Alere San Diego, Inc.
|
Alere Triage TOX Drug Screen 9 Panel, P/N: 94402.
The Alere Triage TOX Drug Screen is a fluoresce...
|
2
|
09/26/2012
|
Alere San Diego, Inc.
|
Alere Triage Tox+MTD Drug Screen, PN 94400
Product Usage:
The Alere Triage TOX Drug Screen is a ...
|
2
|
07/19/2012
|
Alere San Diego, Inc.
|
Total Knee Pack, REF CETJ130, medical convenience kits
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3
|
06/15/2023
|
American Contract Systems, Inc.
|
Clearview hCG Combo with Reference Line, Wampole Laboratories, ABI List No/Product No. 6028KCV; 30 I...
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2
|
11/21/2007
|
Applied Biotech Inc
|
Clearview hCG Combo Waived for urine & Moderate for serum, Wampole Laboratories, ABI List No/Product...
|
2
|
11/21/2007
|
Applied Biotech Inc
|
Hypoguard Advance Micro-draw Blood Glucose Monitoring System, Product Number : 411100, For In Vitro...
|
3
|
12/13/2007
|
ARKRAY USA INC.
|
First Aid Kits containing acetaminophen under brand names Equate (Walmart), Meijer, and Care Science...
|
2
|
05/04/2022
|
ASO LLC
|
CA Cellulose Acetate High Efficiency Hollow Fiber Dialyzers; Model CA 210, product code 5M1736; Dist...
|
2
|
12/04/2003
|
Baxter Healthcare Corp.
|
Baxter Meridian Hemodialysis Instrument, product code 5M5576 and 5M5576R; Baxter Healthcare Corporat...
|
3
|
03/05/2003
|
Baxter Healthcare Corp.
|
EXACTAMIX Empty EVA (Ethylene Vinyl Acetate) TPN Bag with the following product code and sizes:
1...
|
2
|
10/21/2019
|
Baxter Healthcare Corporation
|
Synchron Acetaminophen (ACTM) Reagent, Part Number 472169.
ACTM Reagent when used in conjunction ...
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2
|
09/25/2008
|
Beckman Coulter Inc
|
Synchron Systems Acetaminophen Reagent, part No. 472169.
|
2
|
07/20/2004
|
Beckman Coulter Inc
|
Sekisui Diagnostics Sekure Chemistry Acetaminophen L3K , Ref. 506-30. The firm names on the label a...
|
2
|
09/12/2017
|
Beckman Coulter Inc.
|
BD Microtainer Quikheel Lancet 1.0 mm incision Depth 2.5 mm Incision Length REF 368101 Rx Only Becto...
|
2
|
09/11/2013
|
Becton Dickinson & Company
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Microtainer Safety flow Lancets; Yellow
Sterile Use once and discard;
2.2mm Blade Length;
1.0mm b...
|
2
|
10/18/2007
|
Becton Dickinson & Company
|
Microtainer Safety Flow Lancets; Blue
Sterile Use once and Discard;
1.9mm Blade Length;
1.0 mm Bl...
|
2
|
10/18/2007
|
Becton Dickinson & Company
|
Microtainer Safety Flow Lancets; Green
Sterile, Use Once and Discard;
1.4 mm Blade Length;
1.0mm...
|
2
|
10/18/2007
|
Becton Dickinson & Company
|
G7 Acetabular System, Dual Mobility Acetabular Liner, 40 mm, Size D, Model Number 110024462
|
2
|
03/23/2023
|
Biomet, Inc.
|
RINGLOC ACETABULAR SYSTEM Self-tapping bone screws, Item numbers 103531, 103533, 103534, 103535 - Pr...
|
2
|
12/17/2020
|
Biomet, Inc.
|
(1) RingLoc Bi-Polar Hip System Acetabular Cup ArCom:
Acetabular Bi-Polar Cup, E1 Antioxidant Infu...
|
2
|
10/09/2020
|
Biomet, Inc.
|
Hip Products
Item Number:
1) 110010462 RingLoc Hip System, Acetabular Bi-Polar Cup, 28 MM X 51 MM...
|
2
|
05/28/2020
|
Biomet, Inc.
|
Biomet Cobalt-Chrome Femoral Components, 32MM MOD HEAD COCR -6MM NECK; 32MM MOD HEAD COCR -3 MM NECK...
|
3
|
06/11/2015
|
Biomet, Inc.
|
Mallory/Head Primary Hip System; Size 11, 160 mm, Lateralized Femoral Stem; Ti-6Al-4V; Porous Plasma...
|
3
|
06/11/2015
|
Biomet, Inc.
|
Mallory Head 4 Finned Acetabular Shell 50 mm, PN 13-104150, hip prosthesis component (Ringloc)
|
2
|
02/17/2015
|
Biomet, Inc.
|
Ringloc+ Acetabular Shell Finned 52 mm, PN 16-104152, hip prosthesis component.
|
2
|
02/17/2015
|
Biomet, Inc.
|
Device Brand Name: Sirius Polish Cemented Stem 34B
Device Classification Name: prosthesis, hip, sem...
|
2
|
12/17/2014
|
Biomet, Inc.
|
Sirius Polish Cemented Stem 38C
Catalog Number: 51-199335
Lot Number Identification: 141680, 18092...
|
2
|
12/17/2014
|
Biomet, Inc.
|
G7 Acetabular System Positioning Guide Post, orthopedic surgical instrument for hip prosthesis. PN:...
|
2
|
06/19/2014
|
Biomet, Inc.
|
G7 Acetabular System Positioning Guide Rod, orthopedic surgical instrument for hip prosthesis PN 110...
|
2
|
06/19/2014
|
Biomet, Inc.
|
G7 Acetabular Screw 6.5mmx35mm
Part Number: 010001000
|
2
|
12/13/2013
|
Biomet, Inc.
|
REF S313152 Straight Acetabular Inserter Handle Ringloc
non-sterile
Orthopedic manual surgical i...
|
2
|
03/08/2013
|
Biomet, Inc.
|
Ranawat/Burnstein Acetabular Shell 54mm/Limited Holes/Porous Coated is a metallic, full-hemisphere,...
|
2
|
11/21/2012
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 56 mm Size 24, with Lock Ring, sterile, REF PT...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 60 mm Size 25, with Lock Ring, sterile, REF PT...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 62 mm Size 25, with Lock Ring, sterile, REF PT...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 64 mm Size 25, with Lock Ring, sterile, REF PT...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 66 mm Size 26, with Lock Ring, sterile, REF PT...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 70 mm Size 27, with Lock Ring, sterile, REF PT...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Multi Hole Acetablular Cup, 74 mm Size 28, with Lock Ring, sterile, REF PT...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 48 mm Size 22, with Locking Ring, sterile, ...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 50 mm Size 22, with Locking Ring, sterile, R...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 52 mm Size 23, with Locking Ring, sterile, ...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 54 mm Size 23, with Locking Ring, sterile, ...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 56 mm Size 24, with Locking Ring, sterile, ...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Regenerex (TM) Ringloc +, Limited Hole Acetablular Cup, 60 mm Size 25, with Locking Ring, sterile, ...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 46 mm Size 22 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 48 mm Size 22 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 50 mm Size 23 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 52 mm Size 23 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 54 mm Size 24 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 56 mm Size 24 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 58 mm Size 25 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 60 mm Size 25 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 62 mm Size 26 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 64 mm Size 26 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 66 mm Size 27 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole finned 70 mm Size 28 porous coat, for uncemented use, steril...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 46 mm Size 22 porous coat, for uncemented use, sterile, REF...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 48 mm Size 22, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 50 mm Size 23, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 52 mm Size 23, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 54 mm Size 24, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 56 mm Size 24, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 58 mm Size 25, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 60 mm Size 25, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 62 mm Size 26, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 64 mm Size 26, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 66 mm Size 27, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 68 mm Size 27, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 70 mm Size 28, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 72 mm Size 28, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|
Ringloc + Acetabular Shell limited hole, 76 mm Size 28, porous coat, for uncemented use, sterile, RE...
|
2
|
06/08/2011
|
Biomet, Inc.
|