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U.S. Department of Health and Human Services

Medical Device Recalls
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PRE1055US: Prevena Dressing, 5 Pack (US-ONLY) Product Usage: The Prevena Incision Management Sys... 2 03/05/2014 KCI USA, INC.
PRE2001: Prevena Incision Management Customizable System Box Product Usage: The Prevena Incision... 2 03/05/2014 KCI USA, INC.
PRE2055: Prevena Customizable Dressing 5-Pack Product Usage: The Prevena Incision Management Sys... 2 03/05/2014 KCI USA, INC.
PRE2055US: Prevena Customizable Dressing 5-Pack (US-ONLY) Product Usage: The Prevena Incision Ma... 2 03/05/2014 KCI USA, INC.
PRE2001US: Prevena Incision Management Customizable System Box (US-ONLY) Product Usage: The Prev... 2 03/05/2014 KCI USA, INC.
BG3515-5 US 5mL BioGlue Surgical Adhesive. BioGlue Surgical Adhesive (BioGlue) is indicated for ... 2 05/30/2014 CryoLife, Inc.
Stapler Addendum for the da Vinci Standard Surgical System; da Vinci S System and da Vinci Si Syst... 2 07/02/2014 Intuitive Surgical, Inc.
EndoWrist Stapler System User Manual Addendum and Wall Chart; The EndoWrist Stapler 45 System an... 2 08/08/2014 Intuitive Surgical, Inc.
IMPLANTE DE ORTHOPEDIA - ( I) CAUTERY T IP POLI SHER LIF ( I) BAG SUTURE FLORAL LIF ( I) TUBE S... 1 08/29/2014 Customed, Inc
ORTHO IMPLANT SURGICAL PACK - (1) CAUTERY TIP POLISHER (1) U-DRAPE 60" X 70" WITH TAPE SPLIT 6" ... 1 08/29/2014 Customed, Inc
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