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Customed, Inc Recall: LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) S

Customed, Inc Recall: LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) S is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Customed, Inc; Product: LAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WI

Recalling firmCustomed, Inc
ProductLAPAROSCOPY COLORECTAL SURGICAL PACK code 900-2259A, contains: (1) SOLUTION SURGICAL DURAPREP 26ml LIF (4) DRAPE UTILITY WITH TAPE LIF (3) TOWELS ABSORBENT 15" X 20" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) BLADE SURGICAL# 15 STAINLESS STEEL (1) BLADE SURGICAL# 11 STAINLESS STEEL (1) GOWN IMPERV. EXTRA REINF. XLG AAMI Il l LIF (1) IRRIGATION SUCTION TROMPET DUAL SPIKE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (2) UTILITY BOWL 16oz. LIF (2) PK. STERI STRIP CLOSURE%'' X 4" L/F (1) ACTIFOG WITH FOAM PAD SOLUTION LIF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) MAYO STAND COVER REINFORCED
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-2533-2014
Categorydevice
StatePR
CountryUnited States

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