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Customed, Inc Recall: LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DR

Customed, Inc Recall: LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DR is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Customed, Inc; Product: LAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAY

Recalling firmCustomed, Inc
ProductLAPAROSCOPY PACK- - (1) DRAPE LAP ABDOMINAL WITH POUCH (1) CAMARA DRAPE 9" X 96" LIF (5) TOWELS ABSORBENT 15" X 20" (1) MAYO STAND COVER REINFORCED (1) TABLE COVER REINFORCED 50" X 90" (4) DRAPE UTILITY WITH TAPE (3) DRAPE SHEET 41" X 58" SMS (1) TUBING INSUFFLAT SET W/0 RING ADAPTOR (5) LAP SPONGE PREWASH 18" X 18" XRD (1) GOWN LGE SMS IMPERVIOUS REINFORCED (2) GOWN X-LARGE SMS IMPERV. REINFORCED (2) MEDICINE CUP 2oz. (1) NEEDLE HYPODERMIC 18G X 1% ST. ( 1) BLADE SURG. # 15 CARBON STEEL (1) SYRINGE 10cc WITHOUT NEEDLE LUER LOCK (2) NEEDLE & BLADE COUNTER 1 Oc MAG/CLEAR (1) DRESSING TEGADERM 4
Reason for recallCustomed 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.
ClassificationClass I (most serious — reasonable probability of serious health consequences or death)
StatusTerminated
DistributionWorldwide 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.
Recall initiated20140520
Recall numberZ-2327-2014
Categorydevice
StatePR
CountryUnited States

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