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Terminated

OB PACK - (1) BABY BLANKET PRINTED (1) BABY BEANIES (1) TABLE COVER REINFORCED 50" X 90" LIF (2) LEGGINS W/7'' CUFF 30" X 42" LIF (1) DRAPE UNDERBUTIOCK W/ POUCH 44" X 35" LIF (3) TOWEL ABSORBENT 15" X 20" LIF (1) DRAPE SHEET 41 " X 58" SMS LIF (2) PAD OBSTETRICAL X-LARGE LIF (1) RECEIVING BLANKET 100% COTTON (1) PVP SCRUB 8" STICK SPONGE (1) FEEDING TUBE BFR, 15" LONG LIF (1) BOWL PLASTIC 80oz WITH LID (1) CORD UMBILICAL CLAMP (1) SYRINGE 20cc WITHOUT NEEDLE LUER LOCK LIF (1) SYRINGE 20cc SLIP TIP LIF (1) GOWN LARGE SMS IMPERVIOUS REINFORCED LIF (1) NEEDLE HYPODERMIC 18G X 1% (1) NEEDLE HYPODERMIC 22G X 1% (20) GAUZE SPONGE 4" X 4" 16PL Y (1) EAR ULCER SYRINGE 2oz LIF (1) DRAPE ABDOMINAL WITH TAPE 40" X 54" LIF (2) GLOVE MED FREETOUCH VYNIL POWDER FREE (1) WRAPPER 24" X 24" L/F (1) GOWN IMPERVIOUS EXTRA REINFORCED LARGE TOWEL/WRAP LIF EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA Recall Z-2367-2014 · Posted 2014-08-29

Recalling FirmCustomed, Inc
Recall StatusTerminated
Product CodeOKV
Date Initiated2014-05-20
Date Terminated2017-08-14
Product Quantity18 lots; 1580 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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