BEUDAMED
    FDA Enforcement Class II Ongoing

    Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

    Recall: Z-0711-2024 · Reported January 17, 2024

    Enforcement

    Recall Number
    Z-0711-2024
    Event ID
    93560
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 17, 2024
    Initiation Date
    November 29, 2023
    Classification Date
    January 11, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline Gown Poly W/Breath Sleeves XL AAMIK Level 4 (Eclipse gown), REF SPT-2208CS, 100/pack, Non-Sterile.

    Reason

    Surgical gowns were manufactured with the wrong sleeve.

    Code Info

    Lot #11023060120, UDI (01)40080196029755(11)230615(10)11023060120.

    Distribution

    Distribution was made to MD, OH, TN, TX, and WI. There was no government/military/foreign distribution.

    Quantity

    2,100 gowns