BEUDAMED
    FDA Recall Terminated

    ThromCat Thrombectomy Catheter System. Catalog number 63000-01

    Recall: Z-1115-2007 · Initiated May 21, 2007

    Recall

    Recall Number
    Z-1115-2007
    Event Number
    38055
    Firm
    Kensey Nash Corp
    FEI Number
    1000307073
    Product Code
    MCW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 21, 2007
    Posted
    July 23, 2007
    Terminated
    August 29, 2007
    Address
    735 Pennsylvania Dr, Exton, PA, 19341-1130

    Description

    ThromCat Thrombectomy Catheter System. Catalog number 63000-01

    Reason

    Defective component (power supply)

    Action

    New power supplies were sent directly to Sales Representatives who personally replaced the defective power supplies and returned them to Kensey Nash. A voice mail to all affected KNC Sales Representatives went out on 5/21/07 instructing them to contact the affected accounts immediately.

    Distribution

    Nationwide:The products were shipped to medical facilities in FL, MO, NJ, and TX.

    Quantity

    11 units