Recall Z-2384-2014— 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: PREMIUM LAPAROTOMY PACK - CUSTOMED- (1) DRAPE T LAPAROT 102" X 78" X 121" (1) GOWN XL SMS IMPERVIOUS REINFORCED (1) COVER TABLE REINFORCED 50" X 90" LIF (1) COVER MAYO STAND REINFORCED LIF (4) DRAPE UTILITY WITH TAPE LIF (4) TOWELS ABSORBENT 15" X 20" LIF (5) SPONGE LAP PRE-WASH 18" X 18" XRD LIF (1) YANKAUER SUCTION TUBE W/0 VENT LIF (1) TUBE SUCTION CONNECT~~~ X 12' LIF (1) BLADE SURGICAL #10 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1 0) GAUZE SPONGES 4" X 4" 16PL Y XRD LIF (2) DRAPE SHEET 42" X 55" LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents. (1) GOWN SURG REINFORCED LARGE TOWEL/WRAP. 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.