FDA-Device2020-10-28Class II
SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar.
Sobel Westex
Hazard
Due to non-surgical isolation gowns not meeting all performance test requirements.
Sold states
U.S. Nationwide distribution including in the state of TN. O.U.S.: None
Affected count
3,380,850 gowns
Manufactured in
2670 Western Ave, N/A, Las Vegas, NV, United States
Products
SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0281-2021Don't want to check this manually?
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