Home / Recalls / Sobel Westex / Z-0281-2021

Z-0281-2021 Class II Terminated

Recalled by Sobel Westex — Las Vegas, NV

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)