Sobel Westex recalls SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use…

Recall date

August 13, 2020

Source

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

Recall number

Z-0281-2021

FDA classification

Class II

Brand / firm

Sobel Westex

Sold / distributed

U.S. Nationwide distribution including in the state of TN. O.U.S.: None

Why it was recalled

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

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

What was recalled

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.