BEUDAMED
    FDA Recall Terminated

    HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8

    Recall: Z-0960-2022 · Initiated February 11, 2022

    Recall

    Recall Number
    Z-0960-2022
    Event Number
    89580
    Firm
    Huntleigh Healthcare Ltd.
    FEI Number
    1000589001
    Product Code
    ITX
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    February 11, 2022
    Terminated
    June 12, 2024
    Address
    35 Portmanmoor Road, Cardiff United Kingdom

    Description

    HUNTLEIGH Disposable intraoperative Probe, 8Mhz (box), REF DIPP10, containing 10 individual Disposable Intraoperative Probes, REF DIOP8

    Reason

    Faceplate may become detached from the probe body.

    Action

    The firm notified their consignees by email beginning on 02/11/2022. The notice explained the issue and requested disposal of the probes on site. Distributors were directed to notify their customers. The firm will replace the affected probes.

    Distribution

    US Nationwide distribution in the states of OK, CA, GA, MI, VA.

    Quantity

    150 devices