Device 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.
Z-0281-2021
Product summary
- Firm
- Sobel Westex
- Event
- Event 86351
- Status
- Terminated
- Classification
- Class II
- Quantity
- 3,380,850 gowns
- Official record key
device-enforcement:Z-0281-2021
Official wording
Reason: Due to non-surgical isolation gowns not meeting all performance test requirements.
Code information: 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)
Distribution pattern: U.S. Nationwide distribution including in the state of TN. O.U.S.: None
Derived failure modes
-
Unknown
Due to non-surgical isolation gowns not meeting all performance test requirements.