BEUDAMED
    FDA Recall Terminated

    MDA Simplastin L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969.

    Recall: Z-1239-03 · Initiated July 31, 2003

    Recall

    Recall Number
    Z-1239-03
    Event Number
    27008
    Firm
    bioMerieux
    FEI Number
    3002769706
    Product Code
    GJS
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 31, 2003
    Posted
    October 15, 2003
    Terminated
    May 18, 2004
    Address
    100 Rodolphe Street, Building 1300, Durham, NC, 27712

    Description

    MDA Simplastin L, Product number 252555, 10 vials, 40 ml ea (400 test each), bioMerieux Inc., Box 15969 Durham, North Carolina 27704-0969.

    Reason

    Complaints of prolonged clot times.

    Action

    Consignees were notified via letter on July 31, 2003. The were advised to check remaining inventory and destroy any remaining material of the affected lot numbers. A Customer Response form was attached.

    Distribution

    The product was distributed to hospitals and distributors located nationwide, Brazil, Canada, China, and Japan.

    Quantity

    857 units