Recall Z-2473-2014— Customed, Inc

Class I FDA medical device recall by Customed, Inc, initiated 2014-05-20, terminated 2017-08-14. FDA's recall record names no specific 510(k) clearance for this event. Product: ORTHOPEDIC PACK Ill (1) CUSTOMED CONTENTS: (1) GOWN XL SMS IMPERVIOUS REINFORCED (4) DRAPE UTILITY WffAPE (1) MAYO STAND COVER REINFORCED (1) SUTURE BAG FLORAL (1) DRAPE TOP W/ADHESIVE 108" X 50" STD SMS (1) DRAPE ORTHOPEDIC SPLIT (1) U- DRAPE 60" X 70" WffAPE SPLIT 6 X 21 (1) TABLE COVER REINFORCED 50" X 90" (1) GOWN SURG REINFORCED XLGE TOWEL I WRAP (1) STOCKINETIE IMPERVIOUS 12" X 48" Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.. Reason: Customed has determined that there is the possibility that packaging integrity may be compromised on different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition..

Recalling firm

Customed, Inc

Classification

Class I

Status

Terminated

Initiated

2014-05-20

Terminated

2017-08-14

Firm location

Fajardo, PR, United States

Data sourced from openFDA. This site is unofficial and independent of the FDA.