Recall Z-0281-2021— Sobel Westex
Class II · Terminated
Class II FDA medical device recall by Sobel Westex, initiated 2020-08-13, terminated 2024-07-08. FDA's recall record names no specific 510(k) clearance for this event. 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: Due to non-surgical isolation gowns not meeting all performance test requirements..
- Recalling firm
- Sobel Westex
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-08-13
- Terminated
- 2024-07-08
- Firm location
- Las Vegas, NV, United States
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.