BEUDAMED
    FDA Enforcement Class II Terminated

    Radiofrequency Grounding Pad, REF RF-DGP-L

    Recall: Z-0664-2020 · Reported December 18, 2019

    Enforcement

    Recall Number
    Z-0664-2020
    Event ID
    84272
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Abbott Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 18, 2019
    Initiation Date
    October 14, 2019
    Classification Date
    December 10, 2019
    Termination Date
    July 19, 2021
    Address
    5050 Nathan Ln N, N/A, Plymouth, MN, 55442-3209, United States

    Description

    Radiofrequency Grounding Pad, REF RF-DGP-L

    Reason

    Affected lots were manufactured with the protective release liner in an incorrect orientation. When attempting to remove this disposable release liner, a clear film may be left on the grounding pad which may interfere with patient skin contact and lead to uneven heating.

    Code Info

    UDI: 05415067028914 Batch Numbers: 810319004, 810319005, and 810319021

    Distribution

    nationwide

    Quantity

    8940 devices