Recall Z-0524-06 ยท FTL Mesh, Surgical, Polymeric
Davol, Inc., Sub. C. R. Bard, Inc.
Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206
| Date | Feb 22, 2006 (initiated Dec 22, 2005) |
| Status | Completed |
| Reason | Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula |
| Root cause | Other |
| Action | Davol Inc. notified US Customers by letter on 12/27/05 via Federal Express. Bard Regulatory International was notified 12/22/05 to recall to accounts outside the US. Accounts are requested to return recalled product. A second letter issued dated January 5, 2006 to include additional product codes not identified in the first letter, specifically to the accounts that received those lots. On 3/24 / 06, Davol issued a third Recall Notification for the extended recall to Hospitals and Distributors and a Dear Doctor Letter to Chief of Surgery. |
| Quantity | 31,761 units |
| Distribution | Nationwide Foreign: Australia, Canada, Japan, |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K003323 | COMPOSIX KUGEL MESH, MODEL 0010201,0010202,0010203,0010204,0010205 Davol, Inc., Jan 22, 2001 |