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Completed

Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 7.7'' x 9.7'' (19.6cm x 24.6cm) Code: 0010208

FDA Recall Z-0526-06 · Posted 2006-02-22

Recalling FirmDavol, Inc., Sub. C. R. Bard, Inc.
Recall StatusCompleted
Product CodeFTL
Date Initiated2005-12-22
Product Quantity31,761 units

Reason for Recall

Memory recoil ring could break and potentially lead to bowel perforation and or chronic enteric fistula

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.

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