BEUDAMED
    FDA Recall Terminated

    TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.

    Recall: Z-0833-2007 · Initiated March 28, 2007

    Recall

    Recall Number
    Z-0833-2007
    Event Number
    37701
    Firm
    Kensey Nash Corp
    FEI Number
    1000307073
    Product Code
    FRO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 28, 2007
    Posted
    May 31, 2007
    Terminated
    August 30, 2007
    Address
    735 Pennsylvania Dr, Exton, PA, 19341-1130

    Description

    TriActiv FX Embolic Protection System 7F, Catalog numbers 60040-02 (has 190 cm guidewire) and 60040-03 (has 300 cm guidewire). The devices are comprised of four principal components including the ShieldWire Balloon Guidewire, the Shieldwire Inflator, the FX or LFX Catheter, and the AutoStream Flow Control.

    Reason

    Insufficient wire sealing

    Action

    On 3/26/07, the recalling firm left voice mail message with all sales representatives instructing the sales representatives to contact all TriActiv FX accounts immediately. Recall notices were faxed on 3/28/07 to all accounts which received the product. Recall notices instructed the hospitals to quarantine all FX and to contact their sales representative to arrange for retrieval of the product if they had not already been contacted.

    Distribution

    Worldwide, including USA and Germany.

    Quantity

    427 kits