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Sobel Westex recalls SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use
Recalled October 28, 2020 · FDA recall Z-0281-2021 · Sobel Westex
Hazard
Due to non-surgical isolation gowns not meeting all performance test requirements. · FDA Class II
Units
3,380,850 gowns
Sold at
U.S. Nationwide distribution including in the state of TN. O.U.S.: None
Description
Due to non-surgical isolation gowns not meeting all performance test requirements.
Product
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.
Manufacturer(s)
Sobel Westex
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →