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Customed, Inc recalls GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE C
Recalled September 10, 2014 · FDA recall Z-2428-2014 · Customed
Hazard
Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition. · FDA Class I
Units
29 lots; 2144 units (multiple units per lot)
Sold at
Worldwide Distribution - US (nationwide) in the state of Florida including Puerto Rico (USA); & USVI (St John) and the countries of Tortola, Trinidad, Dominican Republic, Costa Rica and Mexico.
Description
Customed has determined that there is the possibility that packaging integrity may be compromised on differ catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Product
GENERAL PACK - CONTENTS: (4) ABSORBENT TOWEL 15" x 20" LIF (1) MAYO STAND COVER REINFORCED LIF ( 1) NEEDLE & BLADE COUNTER 20c FOAM/MAG LIF (2) UTILITY BOWL 16 oz. LIF (1) GLASINE BAG PLAIN ( 1) SUTURE BAG FLORAL (4) DRAPE UTILITY WITH TAPE LIF ( 1) TABLE COVER REINFORCED 50" X 90" LIF (1) SURGICAL BLADE# 10 STAINLESS STEEL ( 1) SURGICAL DURAPREP SOLUTION 26mL LIF ( 1) LAPAROTOMY T DRAPE STD SMS (2) DRAPE SHEET 41" X 58" SMS LIF (2) GOWN IMPERVIOUS REINFORCED X-LARGE SMS LIF (1 0) GAUZE 4"X 4" X 4 PLY ( 1) CAUTERY TIP POLISHER LIF (5) LAP SPONGES PRE-WASH XRD LIF ( 1) CAUTERY PENCIL ROCKER SWITCH LIF (1 0) GAUZE SPONGE 4" X 4" 16 PLY XRD LIF ( 1) TUBE SUCTION CONNECT. 3/16" X 12' LIF ( 1) SURGICAL BLADE# 15 CARBON STEEL ( 1) CONTAINER SPECIMEN 4 oz. WITH LID & LABEL Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents
Manufacturer(s)
Customed, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →