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U.S. Department of Health and Human Services

Medical Device Recalls

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1 to 10 of 500 Results *
Date Classified to: 09/22/2014 510(K) Number: K101558
 
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0.9% Sodium Chloride Injection, USP BD PosiFlush(TM) SF Saline Flush Syringe 10 mL REF#306553 used ... 2 Sep-19-2014 Centurion Medical Products Corporation
VITROS Immunodiagnostic Products Anti-HCV Reagent Pack for in vitro qualitative detection of immunog... 2 Sep-19-2014 ORTHO-CLINICAL DIAGNOSTICS
98" (249 cm) Appx 12.3 ml, 60 Drop Primary Set w/Pre-Slit Port, STAT 2 Flow Controller, Rotating Lue... 1 Sep-19-2014 ICU Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 20 Drop Primary Set w/2 Clave, STAT 2 Flow Contr... 1 Sep-19-2014 ICU Medical, Inc.
STAT 2 Flow Controller; 80" (203 cm) Appx 14.8 mL, 60 Drop Primary Set w/2 Clave, STAT 2 Flow Contr... 1 Sep-19-2014 ICU Medical, Inc.
CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients... 1 Sep-19-2014 CareFusion 203, Inc.
83" (211 cm) Appx 10.3 mL, 60 Drop Primary Set w/BCV-Clave, Stat 2 Flow Controller, Clave, Rotating ... 1 Sep-19-2014 ICU Medical, Inc.
Siemens CentraLink Data Management System, software version 14. The CentraLink system software ... 2 Sep-18-2014 Siemens Healthcare Diagnostics, Inc.
Rusch, Soft Rubber (Nelaton and Nelaton Robinson), Bladder Catheter, Sterile. These catheters are... 2 Sep-18-2014 Teleflex Medical
The Brilliance CT Big Bore is a whole-body Computed Tomography X-ray system intended to produce cros... 2 Sep-18-2014 Philips Medical Systems (Cleveland) Inc

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