BEUDAMED
    FDA Recall Terminated

    SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S.

    Recall: Z-1981-2011 · Initiated March 17, 2010

    Recall

    Recall Number
    Z-1981-2011
    Event Number
    57776
    Firm
    Hsmg, Inc. D/b/a Smartinfuser Usa
    FEI Number
    3004960040
    Product Code
    MEB
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 17, 2010
    Posted
    April 14, 2011
    Terminated
    April 25, 2011
    Address
    8588 Katy Fwy, Ste 348, Houston, TX, 77024-1822

    Description

    SmartBlock PainPump, Part numbers: P49524-S, P49534-S, P49624-S, and P49634-S.

    Reason

    Elastomeric tube in product's compression unit has the potential to burst following filling.

    Action

    Firm notified consignees by e-mail and telephone on 3/17/2010. The correspondence identified the affected product and lot numbers; and asked that customers specify which parts, lot numbers and in what quantities they still had in their possession.

    Distribution

    Nationwide Distribution

    Quantity

    368 units