BEUDAMED
    FDA Recall Open, Classified

    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 · Initiated September 1, 2022

    Recall

    Recall Number
    Z-0242-2023
    Event Number
    90833
    Firm
    Texas Medical Technology Inc.
    FEI Number
    3016808907
    Product Code
    FYA
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 1, 2022
    Posted
    November 16, 2022
    Address
    1111 Gillingham Ln, Sugar Land, TX, 77478-2865

    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.

    Action

    On 9/1/22, a recall notice was sent to a distributor who was asked to forward the recall notice to their customers. Customers are asked to return the gowns to the distributor and to complete a self-address questionnaire to the recalling firm. The following contact information was provided: 346-250-2655, Monday through Friday 8 AM to 5 PM Central Time, [email protected] On 11/9/22, a follow-up recall notice was sent asking customers to destroy affected gowns.

    Distribution

    US Nationwide distribution in the state of FL.

    Quantity

    100,000