BEUDAMED
    FDA Enforcement Class III Terminated

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

    Recall: Z-0128-2014 · Reported November 13, 2013

    Enforcement

    Recall Number
    Z-0128-2014
    Event ID
    66423
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Helix Medical LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 13, 2013
    Initiation Date
    October 1, 2013
    Classification Date
    November 1, 2013
    Termination Date
    January 21, 2014
    Address
    1110 Mark Ave, N/A, Carpinteria, CA, 93013-2918, United States

    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.

    Code Info

    LOTS: 1057760, 1057919 and 1059222

    Distribution

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

    Quantity

    47 units