BEUDAMED
    FDA Enforcement Class II Terminated

    MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

    Recall: Z-0566-2022 · Reported February 16, 2022

    Enforcement

    Recall Number
    Z-0566-2022
    Event ID
    89290
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 16, 2022
    Initiation Date
    December 22, 2021
    Classification Date
    February 7, 2022
    Termination Date
    August 15, 2023
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    MIC* Percutaneous Endoscopic Gastrostomy PEG Kit with ENFit Connectors - 20 Fr-PULL

    Reason

    The External Retention Bolster contained in the kit may be a larger diameter than the tube.

    Code Info

    1) Code 8160-20, Lot 30135103 2) Code 8640-20, Lot 30132544

    Distribution

    Worldwide distribution - US Nationwide and the countries of Canada and Chile.

    Quantity

    692 units