Recall Z-0010-2013 ยท KOD Catheter, Urological
C.R. Bard, Inc., Urological Division
8 Fr. Bardex Pediatric All-Silicone Foley Catheter with a 3cc balloon. The product is packaged individually with 12 units per corrugated case. The product is sold sterile for single use and is used to provide continuous urinary drainage from the bladder.
| Date | Oct 4, 2012 (initiated Sep 7, 2012) |
| Status | Terminated |
| Reason | The 8 Fr. Bardex All-Silicone Foley Catheter with 3cc balloon had an incorrect inflation volume (10 ml instead of 5 ml) printed on the valve cap. |
| Root cause | Employee error |
| Action | An "Urgent: Product Recall Notification" was sent to all customers and distributors in September 2012 via Federal Express. The letter described the product issue and provided recommended actions. Customers can contact Bard at (770) 784-6471 if questions. |
| Quantity | 4,032 units |
| Distribution | Nationwide distribution: USA and Puerto Rico |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K821745 | BARDEX ALL SILICONE PEDIATRIC CATHETER C.R. Bard, Inc., Jun 24, 1982 |