Recall Z-2374-2014 ยท NWR
Customed, Inc
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 DRAIN
| Date | Aug 29, 2014 (initiated May 20, 2014) |
| Status | Terminated |
| Reason | 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 | Package design/selection |
| 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 Coor |
| Quantity | 13 lots; 12820 units (multiple units per lot) |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.