Class 1 Device Recall Bard

• Date Initiated by Firm: December 22, 2005
• Date Posted: February 22, 2006
• Recall Status: Completed
• Recall Number: Z-0760-06
• Recall Event ID: 34393
• Product Classification: Hernia repair device - Product Code FTL
• Product: Bard Composix Kugel Large Oval, 5.4'' x 7'' for hernia repairs Product Code: 0010202
• Code Information: Lot Numbers: 41*L****, 41*M****, 41*N**** 43*L****, 43*M****, 43*N****
• Recalling Firm/ Manufacturer: Davol, Inc., Sub. C. R. Bard, Inc.; 100 Sockanossett Crossroad; Cranston RI 02920
• For Additional Information Contact: Robin Drago; 401-463-7000 Ext. 2389
• Manufacturer 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)
• FDA Determined 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 in Commerce: 25,890
• Distribution: Nationwide Foreign: Australia, Canada, Japan,
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.