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Terminated

CESAREAN PACK - (1) BABY BLANKET IMP. 30" X 30" POLY ABS. (1) NEEDLE & BLADE COUNTER 60c FOAM/STRIP MAG/STRIP LIF (1) DRESSING ISLAND 4" x 10" (1) CESAREAN DRAPE 71" x 125" LIF (2) GOWN SURG REINFORCED LARGE TOWEL/WRAP (10) LAP SPONGES PREWASH XRD LIF (1) BABY BEANNIES (1) SCALPEL #10 WITH HANDLE STAINLESS STEEL (1) DRAPE SHEET 42" X 57" SMS (1) EAR ULCER SYRINGE 2oz. UF (1) RECEIVING BLANKET 100% COTTON (1) SCALPEL #20 WITH HANDLE (1) DURAPREP SURGICAL SOLUTION 26ml UF (2) ABSORBENT TOWEL 15" X 20" L.F (2) LITE GLOVES UF (1) BOWL WITH LID PLASTIC 80oz. (1) TABLE COVER REINFORCED 44" x 78" LIF (1) UTILITY BOWL 32oz (2) PAD OBSTETRICAL X-LARGE ST. (1) WRAPPER 30" X 30" LIF (1) MAYO STAND COVER REINFORCED LIF (1) TUBE SUCTION CONNECT Y." X 12' UF (1) MUCUSTRAP 20cc 1 OFR (1) YANKAUER SUCTION TUBE WITHOUT VENT UF (1) UMBILICAL CORD CLAMP EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall Z-2405-2014 · Posted 2014-08-29

Recalling FirmCustomed, Inc
Recall StatusTerminated
Product CodeOHM
Date Initiated2014-05-20
Date Terminated2017-08-14
Product Quantity20 lots; 1095 units (multiple units per lot)

Reason for Recall

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.

Firm Action

Customed Inc. sent a Recall Notification letter dated June 3, 2014 via email and followed by letter to all affected customers. The letter identified the affected products, problem and actions to be taken. The letter informed customers if the affected products are in their inventory to: 1. Remove products from sale (quarantine them) and cease distribution. 2. Complete and return the enclosed acknowledgement form to Customed Inc .Recall Coordinator. Affected products should be returned to Customed Inc for credit. Customers with questions were instructed to contact Customed Inc. Recall Coordinator at 1-787-801-0100 Ext. 7540

Root Cause

Package design/selection

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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