BEUDAMED
    FDA Recall Terminated

    PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch package, 6 packages per papercard carton

    Recall: Z-0249-04 · Initiated October 31, 2003

    Recall

    Recall Number
    Z-0249-04
    Event Number
    27682
    Firm
    McKesson General Medical Corporation
    FEI Number
    1120101
    Product Code
    FTL
    Status
    Terminated
    Root Cause
    Other
    Initiated
    October 31, 2003
    Posted
    July 20, 2004
    Terminated
    August 4, 2011
    Address
    5601 Eastport Boulevard, Richmond, VA, 23231

    Description

    PROLENE* Mesh, Polypropylene Non Absorbable Synthetic Surgical Mesh, PMII, 3'x6', each mesh in a sealed pouch package, 6 packages per papercard carton

    Reason

    Counterfeit product is an unapproved medical device with associated potential health hazard.

    Action

    The distributor notified all distribution centers and field personnel by e-mail on 10/29/03. The firm''s centers were instructed to inspect and quarantine lots RBE609 and RJJ130. Field personnel were instructed to notify customers to quarantine counterfeit product and any suspect product. On 10/30/03, the recalling distributor notified its field representatives to inspect and quarantine all lots of the mesh. The firm issued a recall notification with reply form to all consignees receiving surgical mesh product since Jan 03.

    Distribution

    Counterfeit and authentic product had been shipped to 221 hospitals and surgery centers in the continental US.

    Quantity

    180 cartons