FDA-Device2022-11-23Class II
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Texas Medical Technology Inc.
Hazard
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.
Sold states
US Nationwide distribution in the state of FL.
Affected count
100,000
Manufactured in
1111 Gillingham Ln, N/A, Sugar Land, TX, United States
Products
Disposable Surgical Level 3 Gown, Size/Product Code: Large/GWS-03-L-B, XLarge/GWS-03-XL-B, XXLarge/GWS-03-XXL-B
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0242-2023Don't want to check this manually?
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