BEUDAMED
    FDA Enforcement Class II Ongoing

    Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B

    Recall: Z-0242-2023 · Reported November 23, 2022

    Enforcement

    Recall Number
    Z-0242-2023
    Event ID
    90833
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Texas Medical Technology Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 23, 2022
    Initiation Date
    September 1, 2022
    Classification Date
    November 16, 2022
    Address
    1111 Gillingham Ln, N/A, Sugar Land, TX, 77478-2865, United States

    Description

    Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B

    Reason

    Surgical gowns recalled due to gown fabric failing to pass the hydrostatic pressure test so the fabric does not provide the protection needed in a level 3 surgical gown, i.e., blood and other fluid may penetrate the fabric.

    Code Info

    Product Code/UDI-DI/Lots: GWS-03-L-B/00850022960338/1300001, 1300002, 1300003, 1300004; GWS-03-XL-B/00850022960345/1400001, 1400002, 1400003, 1400004; GWS-03-XXL-B/00850022960352/1500001, 1500002, 1500003, 1500004

    Distribution

    US Nationwide distribution in the state of FL.

    Quantity

    100,000