BEUDAMED
    FDA Recall Terminated

    Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3

    Recall: Z-0128-2014 · Initiated October 1, 2013

    Recall

    Recall Number
    Z-0128-2014
    Event Number
    66423
    Firm
    Helix Medical LLC
    FEI Number
    2025182
    Product Code
    EWL
    Status
    Terminated
    Root Cause
    Packaging change control
    Initiated
    October 1, 2013
    Posted
    November 1, 2013
    Terminated
    January 21, 2014
    Address
    1110 Mark Ave, Carpinteria, CA, 93013-2918

    Description

    Blom-Singer Adjustable Tracheostoma Valve II Models: BE8025H and BE8025H-R3

    Reason

    InHealth Technologies (IHT) is recalling the Blom-Singer Adjustable Tracheostoma Valve II (ATSV II) because the body component of the device is missing from the packaging. The ATSV II Valve product cannot be used as intended without the product body.

    Action

    A phone script and a customer notification letter are provided. The recall was initiated on 10/1/13 and customers will be notified that InHealth Technologies, a division of Helix Medical, LLC has initiated a recall of the following 3 lots of the Blom-Singer Adjustable Tracheostoma Valve (BE8025H and BE8025H-R3): 1057760, 1057919 and 1059222. The phone script provides the problem identified and the actions to be taken. Customers are instructed to complete the Customer response form and return by email to [email protected], fax to (805) 566-5381 or by mail to InHealth Technologies, 1110 Mark Avenue, Carpinteria, CA 93013. Customers are also instructed to Contact UPS at 1-800-742-5877 and provide In Health Technologies UPS account no., 846718. UPS will come to your site, package the recalled product(s) and ship it to InHealth Technologies at InHealth Technologies expense. Customers are instructed to respond within 10 days.

    Distribution

    Worldwide Distribution-USA (nationwide) and the countries of Belgium, Canada, Croatia, Germany, Ireland, and Italy.

    Quantity

    47 units