medical Class II Updated 2020-10-28

Sobel Westex recalls SOBEL WESTEX Disposable Isolation Gown Made in China RN#7127

Recalled 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.


Hazard / Issue

Due to non-surgical isolation gowns not meeting all performance test requirements.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Catalog: HGCR4958.45D-C Batch/Lot Numbers: - 20200405 (293,250 gowns manufactured) - 20200425 (1,054,050 gowns manufactured) - 20200502 (60,000 gowns manufactured) - 20200508 (2,033,550 gowns manufactured)
View official government recall

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