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Terminated

ANGIOGRAPHY PACK- - (4) CLOTH HUCK TOWEL BLUE UF (1) TABLE COVER REINFORCED 50" X 90" LIF (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK UF (2) MEDICINE CUP 2oz. LIF (3) UTILITY BOWL 32oz UF (1) EMESIS BASIN 10 IN 700cc (4) TOWEL CLAMP (3) ABSORBENT TOWELS 15" X 20" LIF (1) SYRINGE 3cc WITHOUT NEEDLE LUER LOCK L/F (1) HALSTED MOSQUITO (1) PVP SCRUB 8" STICK SPONGE (1) TRAY PLATFORM LARGE (3) LABELS FOR SKIN MARKERR (1) LABEL FOR MEDICATION SALINE NORMAL BLUE (1) LABEL FOR MEDICATION TRIDIL VIOLETA (1) NEEDLE HYPODERMIC 18G X 1 'h (4) SYRINGE 10ccWITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30cc WITHOUT NEEDLE LUER LOCK LIF (2) UTILITY BOWL 16oz (3) BAND BAG WITH RUBBAND & TAPE LIF (25) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) DRAPE ANGlO 75" X 145" (1) NEEDLE HYPODERMIC 21 G X 1 'h LIF (1) SAFETY SCALPEL #11 LIF (1) GOWN STANDARD SMS LARGE VELCRO NECK (2) NEEDLE HYPODERMIC 23G X 1" (1) TRAY ORGANIZER FULL DEEP (1) GOWN LARGE NON REINFORCED SMS TOWEL & WRAP (1) LABEL XYLOCAINE FOR MEDICATION YELLOW (1) LABEL CONTRASTE FOR MEDICATION GREEN (1) LABEL FOR MEDICATION INTEGRILIN RED (1) PVP PAINT 8" STICK SPONGE EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents

FDA Recall Z-2313-2014 · Posted 2014-08-29

Recalling FirmCustomed, Inc
Recall StatusTerminated
Product CodeOEQ
Date Initiated2014-05-20
Date Terminated2017-08-14
Product Quantity30 lots; 6500 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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