BEUDAMED
    FDA Enforcement Class II Terminated

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

    Recall: Z-0960-2022 · Reported April 27, 2022

    Enforcement

    Recall Number
    Z-0960-2022
    Event ID
    89580
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Huntleigh Healthcare Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    April 27, 2022
    Initiation Date
    February 11, 2022
    Classification Date
    April 20, 2022
    Termination Date
    June 12, 2024
    Address
    35 Portmanmoor Road, Cardiff, N/A, 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.

    Code Info

    Lot Number: (10) 7842006001 UDI: (01) 05051968036537 (10) 784006001 (individual) UDI: (01) 05051968036544 (10) 784006001 (box)

    Distribution

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

    Quantity

    150 devices