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Terminated

AV FISTULA PACK- (1) DRAPE T LAPAROT 102" X 78" X121 " STD SMS (3) GOWN SURG. REINFORCED X-LARGE EXTRA LONG LEVEL IV (1) DRAPE SHEET 42" X 57" SMS (4) DRAPE UTILITY WITH TAPE LIF (1 0) GAUZE SPONGE 4" X 4" 16PL Y XRD LIF (1) PENCIL CAUTERY HAND SWITCHING LIF (1) TUBE SUCTION CONNECT "Y-1" X 12' LIF (1) FRAZIER WITH CONTROL VENT & OBTUR 10F LIF (2) LITE GLOVE LIF (1) BOWL UTILITY 32oz LIF (2) BOWL UTILITY 16oz LIF (10) LAP SPONGE PREWASH XRD LIF (1) SOLUTION SURGICAL DURAPREP 26ML LIF (3) SYRINGE 60ML WITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 30CC WITHOUT NEEDLE LUER LOCK UF (1) SYRINGE 5CC WITH NEEDLE 21G X 1% LUER LOCK UF (2) SYRINGE 3CC WITHOUT NEEDLE LUER LOCK UF (1) NEEDLE HYPODERMIC 18G X 1 % (2) COUNTER NEEDLE & BLADE 10C MAG/CLEAR UF (1) COVER MAYO STAND REINFORCED LIF (1) COVER TABLE 44" X 90" (1) MAYO TRAY SMALL (2) ABSORBENT TOWEL 15" X 20" UF (1) BOWL WITH LID PLASTIC 80oz EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall Z-2419-2014 · Posted 2014-08-29

Recalling FirmCustomed, Inc
Recall StatusTerminated
Product CodeLRO
Date Initiated2014-05-20
Date Terminated2017-08-14
Product Quantity21 lots; 684 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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