Texas Medical Technology Inc. recalls Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B

Recall date

September 1, 2022

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0242-2023

FDA classification

Class II

Brand / firm

Texas Medical Technology Inc.

Sold / distributed

US Nationwide distribution in the state of FL.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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