BEUDAMED
    FDA Recall Terminated

    CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.

    Recall: Z-1909-2008 · Initiated April 11, 2008

    Recall

    Recall Number
    Z-1909-2008
    Event Number
    47856
    Firm
    Medical Components, Inc dba MedComp
    FEI Number
    2518902
    Product Code
    DQX
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    April 11, 2008
    Posted
    September 16, 2008
    Terminated
    October 28, 2008
    Address
    1499 Delp Dr, Harleysville, PA, 19438-2936

    Description

    CMS-MST572 5F insertion kit with 5 cm tearaway. The product is shipped 10 kits per box and is intended for use in percutaneous procedures to introduce and position catheters, pacing leads and other interventional devices within the coronary and peripheral vasculature.

    Reason

    kit contains incorrect component

    Action

    The recalling firm issued recall letters on 4/11/08 via UPS delivery. The letters informed the customers of the problem and the need to return the product.

    Distribution

    The products were shipped to customers in PA and TX.

    Quantity

    100 units