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Customed, Inc recalls Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER
Recalled September 10, 2014 · FDA recall Z-2526-2014 · Customed
Hazard
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. · FDA Class I
Units
1 lot/ 16 units
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 different catalog numbers (multiple lots). This could result in an injury to the patient due to product contamination or loss of sterility condition.
Product
Face Pack FJG, code 900-3116, contains: (2) GOWN LARGE STANDARD SMS AAMIIII (2) TOWEL ABSORBENT 15" X 20" (1) COUNTER NEEDLE & BLADE 20C FOAM/MAG (1) COVER MAYO STAND REINFORCED (1) SHEET ENT SPLIT 11 0" X 77" SMS (1) COVER TABLE REINFORCED 44" X 78" (20) GAUZE SPONGE 4" X 4" 12PL Y (6) TOWEL CLOTH HUCK BLUE (1) PK. STRIP STERI CLOSURE W X 4" (2) CUP DENTURE 8oz TEAL WITH LID (1) SKIN MARKER WITH RULER (1) RULER (1) SYRINGE 10CC WITHOUT NEEDLE LUER LOCK (1) SHEET o/. DRAPE 60" X 77" REINFORCED (1) BLADE SURG. #15 CARBON STEEL (1) BLADE SURG. #10 CARBON STEEL (4) DRAPE UTILITY WITH TAPE (1) SYRINGE BULB 60CC (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 6.5 P/F (2) Prs. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7 P/F (1) Pr. GLOVE SURG. CUSTOMGUARD CHLOROPRENE # 7.5 P/F (1) YANKAUER SUCTION TUBE WITHOUT VENT (1) TUBE SUCTION CONNECT%'' X 12' (1) CAUTERY PENCIL PUSH BOTIOM HOLSTER 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 →