BEUDAMED
    FDA Enforcement Class II 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 · Reported September 5, 2018

    Enforcement

    Recall Number
    Z-2926-2018
    Event ID
    80562
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stanbio Laboratory, LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 5, 2018
    Initiation Date
    February 8, 2018
    Classification Date
    August 24, 2018
    Termination Date
    September 4, 2020
    Address
    1261 N Main St, N/A, Boerne, TX, 78006-3014, United States

    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.

    Code Info

    Serial number range of affected power adapters: 41800001-41804000

    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