Recall Z-2591-2015 ยท KNX Collector, Urine, (And Accessories) For Indwelling Catheter
Customed, Inc
FOLEY CATH KIT 16FR. W/FOLEY S SENSOR 20/CS Used by medical staff to perform surgical procedures and patient care procedures such as wound healing, suture removals, irrigate wounds, etc. .
| Date | Sep 3, 2015 (initiated Jul 10, 2015) |
| Status | Terminated |
| Reason | Recall initiated due to inadequate validation/qualification of sterilization processes, and package integrity for products released for distribution as sterile. |
| Root cause | Packaging |
| Action | Customed issued an "URGENT VOLUNTARY MEDICAL DEVICE RECALL" notification letter dated July 10, 2015 to all affected customers. The letter identified the product, problem, and actions to be taken by the customer. |
| Quantity | 160 |
| Distribution | Distributed Only in Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K962652 | URINARY DRAINAGE BAG, (REORDER NO. 0749 - PRODUCT NO. 900-749) Customed, Inc., Oct 4, 1996 |