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Class 1 Device Recall Bard |
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Date Initiated by Firm |
December 22, 2005 |
Date Posted |
February 22, 2006 |
Recall Status1 |
Completed |
Recall Number |
Z-0526-06 |
Recall Event ID |
34393 |
Product Classification |
Hernia repair device - Product Code FTL
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Product |
Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm) Code: 0010208 |
Code Information |
Lot Codes: 41XMXXXX ¿ M = 2002, 41XNXXXX ¿ N = 2003, 43XMXXXX ¿ M = 2002, 43XNXXXX ¿ N = 2003, 43XOXXXX ¿ O = 2004, 43XPXXXX ¿ P = 2005. If the lot number does not contain either M, N, O or P as the 4th character the lot is not affected by this recall. |
Recalling Firm/ Manufacturer |
Davol, Inc., Sub. C. R. Bard, Inc. 100 Sockanossett Crossroad Cranston RI 02920
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For Additional Information Contact |
Robin Drago 401-463-7000 Ext. 2389
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Manufacturer Reason for Recall |
Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula
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FDA Determined Cause 2 |
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 |
31,761 units |
Distribution |
Nationwide
Foreign: Australia, Canada, Japan, |
Total Product Life Cycle |
TPLC Device Report
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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.
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