BEUDAMED
    FDA Recall Terminated

    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

    Recall: Z-2926-2018 · Initiated February 8, 2018

    Recall

    Recall Number
    Z-2926-2018
    Event Number
    80562
    FEI Number
    1616487
    Product Code
    GKR
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    February 8, 2018
    Terminated
    September 4, 2020
    Address
    1261 N Main St, Stanbio Laboratory, LP, Boerne, TX, 78006-3014

    Description

    Stanbio AC power adapter for the HemoPoint H2 meter, Model G3000 series. The firm name on the label for the HemoPoint H2 shows Manufactured by EKF-diagnostic GmbH, Germany.

    Reason

    The US prong (type A) adapter plate may crack, break, or detach and remain in the electrical outlet exposing live electrical contacts.

    Action

    The recall was initiated via letter dated 2/7/2018 by first class mail letter on 2/8/2018 instructing the consignee to stop using the adapter if it is affected and it will be replaced.

    Distribution

    Distribution was nationwide. There was military distribution and no government distribution. Foreign distribution was made to Bolivia, Malaysia, Mexico, Papua New Guinea, Paraguay, Philippines, and Suriname.

    Quantity

    2,804 devices