FDA recall Z-0281-2021

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.

Reason for recall

Due to non-surgical isolation gowns not meeting all performance test requirements.

Distribution

U.S. Nationwide distribution including in the state of TN. O.U.S.: None

Key facts

Status

Terminated

Initiation date

2020-08-13

Report date

2020-10-28

Termination date

2024-07-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Las Vegas, NV, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0281-2021