BEUDAMED
    FDA Recall Terminated

    Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    Recall: Z-1649-2010 · Initiated March 5, 2010

    Recall

    Recall Number
    Z-1649-2010
    Event Number
    54884
    Firm
    Ram Medical Inc
    FEI Number
    1000222355
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 5, 2010
    Posted
    June 8, 2010
    Terminated
    June 6, 2016
    Address
    4 Haul Rd, Wayne, NJ, 07470-6625

    Description

    Bard Mesh Monofilament Knitted Polypropylene; size 3" x 6", 3 units per box. Davol Inc. A Subsidiary of C.R. Bard, Inc. 100 Sockanossett Crossroad Cranston, RI 02920. Intended as reinforcement of soft tissue where weakness exists.

    Reason

    Counterfeit product mixed with authentic product. The problem was recognized by the mismatching of expiration dates and the subtle differences in packaging.

    Action

    Ram Medical Inc., contacted Customers by phone beginning March 4, 2010 and issued "Urgent Device Recall" notifications beginning March 8, 2010. Further notifications were issued to expand the scope of the recall by the firm. Each notification described the affected product and asked the User to complete a Recall Acknowledgement Form and return it to the firm. All affected product should be returned to the firm. For further information, contact Ram Medical, Inc. at 1-973-633-0400 Monday through Friday, 9:00 AM to 5:00 PM EST.

    Distribution

    Nationwide Distribution -- CO, IL , NY, MO and FL.

    Quantity

    135 boxes of lor 43HPD027, 25 boxes of 43HPD032; 42 boxes of HUSG0540