Reported Oct 28, 2020 · Terminated
SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven laminate with PE Film - Product Usage: use…
Sobel Westex
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Sobel Westex · 2670 Western Ave · Las Vegas, NV · 89109-1112
Is this the product you have?
- SOBEL WESTEX Disposable Isolation Gown Made in China RN#71273 SBPP non woven
- laminate with PE Film - Product Usageuse in patient/healthcare personnel interactions. AAMI Level II isolation gowns are intended for relatively low risk procedures, including blood draws, lab work, or similar
- Lot codes and dates
- CatalogHGCR4958.45D-C
- Batch/Lot Numbers
- 20200405 (293250 gowns manufactured) - 20200425 (1054050 gowns manufactured) - 20200502 (60000 gowns manufactured) - 20200508 (2033550 gowns manufactured)
- Amount recalled
- 3,380,850 gowns
Where it was sold
- Nationwide
- TN
Why it was recalled
Due to non-surgical isolation gowns not meeting all performance test requirements.
This product could cause temporary or reversible health problems — stop using it.
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