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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: 07/04/2014 510(K) Number: K101558
 
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CareFusion EnVe and ReVel Ventilators. The EnVe/ ReVel Ventilator is designed for use on patients... 1 Sep-19-2014 CareFusion 203, 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.
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.
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.
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.
LAPAROSCOPY GYN PACK - (1) TABLE COVER REINFORCED 44" X 78" (1) LAPAROSCOPY SHEET "T" SMS (3) T... 1 Aug-29-2014 Customed, Inc
ARTHROSCOPY PACK - (1) MAYO STAND COVER REINFORCED LIF (1 0) GAUZE SPONGES 4" X 4" 16PL Y (1) T... 1 Aug-29-2014 Customed, Inc
O.R. TOWELS- CUSTOMED- (6) TOWELS CLOTH HUCK BLUE ( I) WRAPPER 20" X 20 EO sterilized surgical ... 1 Aug-29-2014 Customed, Inc
FANFOLD DRAPE - CUSTOMED (1) DRAPE SHEET 42" X 57" SMS (1) WRAPPER 24" X 24" EO sterilized surg... 1 Aug-29-2014 Customed, Inc
PERY GYN PACK- (1) DRAPE UTILITY WITH TAPE UF (1) UNDERBUTTOCK DRAPE WITH POUCH (2) ABSORBENT ... 1 Aug-29-2014 Customed, Inc

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