BEUDAMED
    FDA Recall Terminated

    Radiofrequency Grounding Pad, REF RF-DGP-L

    Recall: Z-0664-2020 · Initiated October 14, 2019

    Recall

    Recall Number
    Z-0664-2020
    Event Number
    84272
    Firm
    Abbott Medical
    FEI Number
    3005334138
    Product Code
    GXD
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    October 14, 2019
    Terminated
    July 19, 2021
    Address
    5050 Nathan Ln N, Plymouth, MN, 55442-3209

    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.

    Action

    The firm initiated the recall by letter hand delivered by an Abbott field representative. The letter requested that consignee cease use of the affected lot and return the product with the aid of a field representative.

    Distribution

    nationwide

    Quantity

    8940 devices