BEUDAMED
    FDA Enforcement Class II Ongoing

    Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734

    Recall: Z-0343-2023 · Reported December 7, 2022

    Enforcement

    Recall Number
    Z-0343-2023
    Event ID
    91122
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Owens & Minor Distribution, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    December 7, 2022
    Initiation Date
    October 31, 2022
    Classification Date
    November 30, 2022
    Address
    9120 Lockwood Blvd, Mechanicsville, VA, 23116-2015, United States

    Description

    Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734

    Reason

    Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection

    Code Info

    UDI-DI: 10680651417340 Lot Number: AH1215T51

    Distribution

    IL, IN, WV

    Quantity

    72 cases (2160 pouches)