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U.S. Department of Health and Human Services

Class 1 Device Recall Bard

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 Class 1 Device Recall Bardsee related information
Date Initiated by FirmDecember 22, 2005
Date PostedFebruary 22, 2006
Recall Status1 Completed
Recall NumberZ-0524-06
Recall Event ID 34393
510(K)NumberK003323 
Product Classification Hernia repair device - Product Code FTL
ProductBard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 8.7'' x 10.7'' Code: 0010206
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
For Additional Information ContactRobin 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
FDA Determined
Cause 2		Other
ActionDavol 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 Commerce31,761 units
DistributionNationwide Foreign: Australia, Canada, Japan,
Total Product Life CycleTPLC 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.
510(K) Database510(K)s with Product Code = FTL
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