FDAAugust 13, 2020device
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 recall recorded by the U.S. Food & Drug Administration.
The hazard
Due to non-surgical isolation gowns not meeting all performance test requirements.
What to do
FDA enforcement status: Terminated
Brands named
sobel westexsobel
Recall history
No related federal recalls on record for this brand yet.
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