BEUDAMED
    FDA Recall Terminated

    ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.

    Recall: Z-0597-2007 · Initiated February 7, 2007

    Recall

    Recall Number
    Z-0597-2007
    Event Number
    37393
    Firm
    Kensey Nash Corp
    FEI Number
    1000307073
    Product Code
    MCW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    February 7, 2007
    Posted
    March 8, 2007
    Terminated
    June 12, 2007
    Address
    735 Pennsylvania Dr, Exton, PA, 19341-1130

    Description

    ThromCat Thrombectomy Catheter System. 7F 2.5 -7.0 mm 150 cm. Catalogue number 63000-01. It is a single-use, disposable device that is used to perform percutaneous maceration and removal of thrombus and restoration of blood flow.

    Reason

    Face seal may wear excessively and cause particulate matter.

    Action

    On 2/7/07, a voice mail message was sent to all KNC Sales Representatives instructing them to contact affected accounts immediately. On 2/9/07, recall notices were faxed to all affected accounts that had affected product. The recall notices instructed hospitals to quarantine the affected lots and to contact their KNC Sales Representative to arrange for retrieval of the product.

    Distribution

    Nationwide.

    Quantity

    165 units