Z-0281-2021 Class II Terminated
FDA device recall Z-0281-2021 was initiated by Sobel Westex on August 13, 2020 and is designated Class II. Reason for recall: Due to non-surgical isolation gowns not meeting all performance test requirements. The recall status is terminated (terminated July 8, 2024). Affected quantity: 3,380,850 gowns.
Recall Details
- Product Type
- Devices
- Report Date
- October 28, 2020
- Initiation Date
- August 13, 2020
- Termination Date
- July 8, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3,380,850 gowns
Product Description
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.
Reason for Recall
Due to non-surgical isolation gowns not meeting all performance test requirements.
Distribution Pattern
U.S. Nationwide distribution including in the state of TN. O.U.S.: None
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)