BEUDAMED
    FDA Recall Completed

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207

    Recall: Z-0525-06 · Initiated December 22, 2005

    Recall

    Recall Number
    Z-0525-06
    Event Number
    34393
    Firm
    Davol, Inc., Sub. C. R. Bard, Inc.
    FEI Number
    1213643
    Product Code
    FTL
    Status
    Completed
    Root Cause
    Other
    Initiated
    December 22, 2005
    Posted
    February 22, 2006
    Address
    100 Sockanossett Crossroad, Cranston, RI, 02920

    Description

    Bard Composix Kugel Mesh X-Large Patch Oval with ePTFE, 10.8'' x 13.7'' (25.4cm x 33cm) Code: 0010207

    Reason

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

    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.

    Distribution

    Nationwide Foreign: Australia, Canada, Japan,

    Quantity

    31,761 units