BEUDAMED
    FDA Recall Terminated

    Inject 10 Coronary Control Syringe (CCS), 10ml

    Recall: Z-0912-03 · Initiated May 16, 2003

    Recall

    Recall Number
    Z-0912-03
    Event Number
    26356
    Firm
    Merit Medical Systems, Inc
    FEI Number
    1721504
    Product Code
    FMF
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 16, 2003
    Posted
    June 5, 2003
    Terminated
    July 21, 2003
    Address
    1600 West Merit Parkway, South Jordan, UT, 84095

    Description

    Inject 10 Coronary Control Syringe (CCS), 10ml

    Reason

    Cracks in the syringe barrels could allow for air aspiration into the syringe barrel.

    Action

    On 5/16/2003, all distributors and consignees were notified by letter.

    Distribution

    Nationwide. Foreign distribution to France, Malaysia, Taiwan, Dominican Republic.

    Quantity

    7257 units