BEUDAMED
    FDA Enforcement Class II Terminated

    CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.

    Recall: Z-0370-2020 · Reported November 20, 2019

    Enforcement

    Recall Number
    Z-0370-2020
    Event ID
    84021
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Avanos Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 20, 2019
    Initiation Date
    October 8, 2019
    Classification Date
    November 14, 2019
    Termination Date
    March 16, 2022
    Address
    5405 Windward Pkwy, N/A, Alpharetta, GA, 30004-3894, United States

    Description

    CORFLO* Percutaneous Endoscopic Gastrostomy (PEG) Kit, Labeled as CORFLO* PEG Kit. 2 units per case The devices could be branded as Halyard Health.

    Reason

    The connector piece to the PEG tube does not pass over the guidewire.

    Code Info

    Catalog Number: 30-4020 (Lot Numbers:0203145253, 0203081127); Catalog Number: 30-4320 (Lot Numbers: 0002994173, 0202974008, 0202907370, 0203201718, 0203241065)

    Distribution

    Distribution to CT, IN, MD, NJ, PA, VA. International distribution to Great Britain.

    Quantity

    104 cases (208 units) total