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U.S. Department of Health and Human Services

Medical Device Recalls

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Date Classified to: 07/04/2014 510(K) Number: K101558
 
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FIRMap 60mm Catheter; Size: 60 mm; Length 50.4 inches French Size Diameter: 8.5F (2.84mm) Model n... 3 Aug-28-2015 Abbott Electrophysiology
Getinge 86 Series Washer/Disinfector with G1 control system software, Model 8666 and Model 8668. For... 3 Aug-25-2015 Getinge Sourcing LLC
BD Vacutainer SST Plus Blood Collection Tubes, 5.0 mL, 13 x 100 mm, Sterile. Provides a means of c... 3 Aug-20-2015 Becton Dickinson & Company
Xpert CT/NG Urine Specimen Collection Kit Part number GXCT/NGURINE-50; Microbiology: Xpert CT/NG... 3 Aug-20-2015 Cepheid
Xpert CT /NG Vaginal/Endocervical/ Specimen Collection Kit: Part number CT/NGSWAB-50; Microbiolo... 3 Aug-20-2015 Cepheid
Mission -Breath Alcohol Detector -15 tests - 0.08% BAC - Blow bags included Product Usage:... 3 Jul-30-2015 Acon Laboratories, Inc.
BD Flow Cytometers; used on all BD FACSCount, BD FACSCalibur, BD FACSCanto, BD FACSCanto II, BD LSR ... 3 Jul-16-2015 BD Biosciences, Systems & Reagents
G7 Variant Elution Buffer HiS no. 1 (M) component of the Tosoh Automated Glycohemoglobin Analyzer HL... 3 Jul-14-2015 Tosoh Bioscience, Inc.
Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (f... 3 Jul-09-2015 Volk Optical Inc
PowerPICC SOLO Catheter with Tip Location System (TLS) Stylet 4F Nurse Full Tray with Microintroduce... 3 Jul-08-2015 Bard Access Systems

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