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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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CORFLO-Ultra Jejunal Tube with CORLOCK-Twoomey Y-Adaptor for use with the CORFLO-Max PEG; enteral fe...
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2
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02/22/2012
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Corpak Med Systems
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Dade(R) Actin(R) FSL Activated PTT Reagent
Product Usage:
Liquid purified soy and rabbit brain ...
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2
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02/16/2012
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Siemens Healthcare Diagnostics, Inc.
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Temporary Pacing Wire, BIPOLAR, Models BM, V, VE and VF, Rx Only, STERILE/EO, Single use only -- Mce...
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2
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02/15/2012
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European Custom Manufacturing B.V.
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DUET TRS 60 4.8MM ARTICULATING SULU
Product Code: DUET6048A
Product Usage:
The ENDO GIA UNIVE...
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2
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02/13/2012
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Covidien LP
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Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Toug...
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2
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01/25/2012
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Gunnell, Inc.
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Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab MAC ...
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2
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01/25/2012
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Gunnell, Inc.
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Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Bariatric ...
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2
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01/25/2012
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Gunnell, Inc.
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Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab RAM
...
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2
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01/25/2012
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Gunnell, Inc.
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Gas cylinders used in Gunnell manual wheelchairs with dynamic recline feature, including: Rehab Kids...
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2
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01/25/2012
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Gunnell, Inc.
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Hospira Blood Set, with 200 Micron Filter, 80 Inch, Non-DEHP; an Rx sterile medical device used to a...
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2
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01/19/2012
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Hospira Inc.
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Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Baxter Healthcare Corpo...
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2
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01/13/2012
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Baxter Healthcare Corp.
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Baxter Colleague 3 Triple Channel Volumetric Infusion Pump. Baxter Healthcare Corporation, Medicatio...
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2
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01/13/2012
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Baxter Healthcare Corp.
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Outer Carton labeled in part:" 1-DAY ACUVUE MOIST BRAND CONTACT LENSES WITH LACREON FOR ASTIGMATISM*...
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3
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01/12/2012
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Johnson & Johnson Vision Care, Inc.
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ETCO2 Divided Sampling Cannula with Simultaneous Oxygen Delivery, Model number 4707 7-7-24.
Salte...
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2
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01/11/2012
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SALTER LABS
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Octopus 900 Perimeter, EyeSuite Perimetry version i4.000 (Flash v. 2.1.4 & 2.1.5), Model Number: Oc...
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2
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01/11/2012
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Haag-Streit USA Inc
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Raymond Laser alignment guide - Model #1096597/002 Red Laser.
Intended to assist operators in per...
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2
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01/11/2012
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The Raymond Corporation
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Raymond Laser alignment guide - Model #1096597/001 Green Laser.
Intended to assist operators in p...
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2
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01/11/2012
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The Raymond Corporation
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LigaSure V 5 mm Dolphin Tip Laparoscopic 37 cm Sealer/Divider, LS1500, Sterile EO, Manufactured for ...
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2
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01/11/2012
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Covidien, PLC
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LigaSure V 5 mm Dolphin Tip Open 20 cm Sealer/Divider, LS1520, Sterile EO, Manufactured for Valleyla...
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2
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01/11/2012
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Covidien, PLC
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MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2092, 45 cm suture and needle, packaged in in...
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2
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01/11/2012
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Mani, Inc. - Kiyohara Facility
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MANI Needle and Suture Pack, 8-0 PGA Absorbable, Model 2090, 30 cm suture and needle, packaged in in...
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2
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01/11/2012
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Mani, Inc. - Kiyohara Facility
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MANI Needle and Suture Pack, 5-0 PGA Absorbable, Model 3391, 45 cm suture and needle, packaged in in...
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2
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01/11/2012
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Mani, Inc. - Kiyohara Facility
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MANI Needle and Suture Pack, 7-0 PGA Absorbable, Model 2091, 30 cm suture and needle, packaged in in...
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2
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01/11/2012
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Mani, Inc. - Kiyohara Facility
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MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2490, 45 cm suture and needle, packaged in in...
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2
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01/11/2012
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Mani, Inc. - Kiyohara Facility
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MANI Needle and Suture Pack, 6-0 PGA Absorbable, Model 2890, 45 cm suture and needle, packaged in in...
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2
|
01/11/2012
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Mani, Inc. - Kiyohara Facility
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SoftMic GUI versions: 4.0.3.0-4.0.3.15, 4.0.4.1-4.0.4.7.
SoftMic is a laboratory information syst...
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2
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01/11/2012
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SCC Soft Computer
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SoftLab GUI versions: 3.18.1.0-3.18.1.21; 3.19.1.0-3.19.1.25; 3.19.2.0-3.19.2.21; 4.0.0.2; 4.0.1.0-4...
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2
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01/11/2012
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SCC Soft Computer
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SoftLab used with SA INST 4.0.2.0 to 4.0.2.51, 4.0.3.0 to 4.0.3.13, 4.5.0.0 to 4.5.0.9, 4.5.2.0 to 4...
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3
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01/11/2012
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SCC Soft Computer
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SoftPath GUI versions: 4.2.3.3-4.2.3.6 and 4.3.0.5-4.3.0.12.
SoftPath is a laboratory information...
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2
|
12/02/2011
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SCC Soft Computer
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SoftPath GUI Versions: 4.3.0.10, 4.3.0.11, and 4.3.0.12.
SoftPath is a laboratory information sy...
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2
|
12/02/2011
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SCC Soft Computer
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ON-Q Silver Dressing is a Antimicrobial wound dressing containing silver. It is individually wrapp...
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2
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11/29/2011
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Acrymed Incorporated
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ImmuneTech brand MyAllergyTest, Specimen Collection Kit, Part No.
8001; Individually Packaged K...
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2
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11/25/2011
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Immunetech Inc
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Hospira LifeShield Latex-Free 150 mL Burette Set, with Calibrated Burette and 2 Clave Ports, Convert...
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2
|
11/25/2011
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Hospira Inc.
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SoftLab GUI versions 4.0.2.8-4.0.2.10; 4.0.3.12-4.0.3.13; and 4.0.4.1-4.0.4.4.
SoftLab is a la...
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2
|
11/23/2011
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SCC Soft Computer
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Peri-Strips Dry with Veritas Collagen Matrix Staple Line Reinforcement (PSDV), sterile EO, Rx Only, ...
|
3
|
11/23/2011
|
Synovis Surgical Inovation Div. of
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IMPAX CardioVascular (CV) Admin Tool
The IMPAX Cardiovascular suite is a cardiovascular informati...
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2
|
11/23/2011
|
AGFA Corp.
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Rapid Strand Rx; the RAPID Strand Rx kit consists of custom loaded absorbable seeding spacers and I-...
|
2
|
11/22/2011
|
Medi-Physics Inc. dba GE Healthcare
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Software: SA BASE 3.1.4.x, 3.1.6.x and SA LabMic 4.0.0.x, 4.0.1.x, 4.0.2.x, 4.0.3.x, 4.0.4.x.
...
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2
|
11/21/2011
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SCC Soft Computer
|
IMPAX Cardiovascular Results Management (RM) Software Versions RM 2.04.37.04 to RM 7.8 SU2
The IM...
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2
|
11/18/2011
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AGFA Corp.
|
IMPAX CV Echo Measurement Import via Optical Character Recognition (OCR)
The IMPAX Cardiovascula...
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2
|
11/18/2011
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AGFA Corp.
|
EHEC Kit Lot# 608096 Containing: Sample Diluent 18.8 ml Lot# 8602EXP.1-BUF WASH 20X II 100.0ml.Lot# ...
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2
|
11/17/2011
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Meridian Bioscience Inc
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SoftPath GUI versions: 3.17.5 to 3.17.9, 4.2.1 to 4.2.3, and 4.3.0 to 4.3.0.4.
SoftPath is a lab...
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2
|
11/17/2011
|
SCC Soft Computer
|
Baxter System 1000 Tina Single Patient Hemodialysis Delivery System; Baxter Healthcare Corporation, ...
|
2
|
11/07/2011
|
Baxter Healthcare Renal Div
|
ARCHITECT Cyclosporine; an in-vitro diagnostic chemiluminescent microparticle immunoassay (CMIA) for...
|
2
|
11/04/2011
|
Abbott Laboratories
|
AR ManoShield, MSS-3599, 10 pack.
FGS: MSS-3599,
Individual package label: LBL-110275-03,
Box ...
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2
|
10/28/2011
|
Sierra Scientific Instruments Inc
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Instrument Manager -Software Versions 8.05, 8.06, 8.07, 8.08, and 8.09.
It is a stand-alone soft...
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2
|
10/21/2011
|
Data Innovations, Inc.
|
MDC PACS - release R2.3 SP1 .
Phillips Healthcare
Andover, Massachusetts
A software applicatio...
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2
|
10/07/2011
|
Philips Healthcare Inc.
|
OPMI® Pentero®, OPMI® Pentero® C, OPMI® Pentero® 900,
OPMI® Vario/S8, OPMI® Vario/S88, OPMI® Neuro ...
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2
|
09/23/2011
|
Carl Zeiss Meditec, Inc.
|
Wound Dressing Kit - Tier I, 10 MM Flat Drain; product code 0877061.
Medela Healthcare,
McHenry, ...
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2
|
09/08/2011
|
Medela Inc
|
TiLite ZR and ZRA Series 2 are mechanical wheelchairs. Devices are sold under brand name TiLite.
...
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2
|
09/07/2011
|
TiSport, Llc
|