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Terminated

SHOULDER PACK- CUSTOMED- (1) TABLE COVER REINFORCED 50" x 90" LIF (2) MAYO STAND COVER REINFORCED L/F (1) U-DRAPE 60" X 70" WITH TAPE SPLIT (4) TOWELS ABSORBENT 15" X 20" LIF (4) DRAPE UTILITY WITH TAPE LIF (2) GOWN IMPERVIOUS EXTRA REINFORCED LARGE (1) SHEET DRAPE 70" X 100" SMS LIF (1) CUP SPECIMEN WITH CAP 4oz (1) TUBE SUCTION CONNECT. Y." X 12' LIF (1) SKIN MARKER WITH RULER (1) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (1) BAG SUTURE FLORAL LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) NEEDLE HYPODERMIC 21G X 1% LIF (1) BLADE SURGICAL #11 CARBON STEEL (1) BLADE SURGICAL #15 CARBON STEEL (1) NEEDLE & BLADE COUNTER 60C FOAM STRIP/MAG STRIP LIF (1) NEEDLE SPINAL ANESTH. 18G X 3% LIF (1) STOCKINETIE IMPERVIOUS 14" X 48" LIF (1) DRAPE BEACH CHAIR SHOULDER ARTHROSC. (1) GOWN SURG. REINFORCED X-LARGE TOWEL/WRAP (2) GAUZE SPONGE 4" X 4" 16PL Y XRD L/F Product Usage: EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall Z-2426-2014 · Posted 2014-08-29

Recalling FirmCustomed, Inc
Recall StatusTerminated
Product CodeOJH
Date Initiated2014-05-20
Date Terminated2017-08-14
Product Quantity16 lots; 327 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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