Bard Composix Kugel Oval, 6.3'' x 12.3'' for hernia repairs Product Code: 0010209
FDA Recall Z-0762-06 · Posted 2006-02-22
Recalling FirmDavol, Inc., Sub. C. R. Bard, Inc.
Recall StatusCompleted
Product CodeFTL
Date Initiated2005-12-22
Product Quantity3,069
Reason for Recall
Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula. (Extension of recall Z-0524/0526-06)
Firm 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.
Root Cause
Other
Distribution Pattern
Nationwide Foreign: Australia, Canada, Japan,
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.