—#129268

Product

FOLEY CATHETER KIT 1118FR.- CUSTOM ED CONTENTS: (1) WRAPPER 24" X 24" (1) LABEL ID PATIENT (1) TRAY ORGANIZER (1) PVP TRIPLE SWABSTICK IODOPHOR (2) GLOVE MED FREETOUCH VYNIL P/F (1) JELLY LUBRICATING 5 GRAM (1) TOWEL 3PL Y POLY 17" X 18" (2) SWABSTICK DRY COTTON (1) DRAPE 4" FENESTRATED 18" X 26" (1) CATHETER FOLEY 18FR, 2WAY SILICONE COATED m SYRINGE 10ccWATERPREFIL UF (1) BAG URINARY DRAINAGE 2000ML ANTI-REFLUX UF (1)SPECIMEN CONTAINER 4oz W/LID & LABEL EO sterilized surgical convenient packs packaged into polyester/polyethylene breather bag with Tyvek double vents.

FDA product code: NWR
Affected lot / code info: Product code 900-1139, 13 lots: 111112985 111123474 112010023 112041179 112072768 112083208 112093742 112103742 112114377 113015573 113109708 140211533 140412580

Why it was recalled

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.

Root cause (FDA determination)

Package design/selection

Action the firm took

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

Recalling firm

Firm: Customed, Inc Calle Igualdad Final # 7
Address: Fajardo, Puerto Rico 00738

Distribution

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.

Timeline

Recall initiated: 2014-05-20
Posted by FDA: 2014-08-29
Terminated: 2017-08-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #129268. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.