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.
Reported: October 28, 2020 Initiated: August 13, 2020 #Z-0281-2021
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.
Details
- Recalling Firm
- Sobel Westex
- Units Affected
- 3,380,850 gowns
- Distribution
- U.S. Nationwide distribution including in the state of TN. O.U.S.: None
- Location
- Las Vegas, NV
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Sobel Westex. Units affected: 3,380,850 gowns.
Why was this product recalled? ▼
Due to non-surgical isolation gowns not meeting all performance test requirements.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on October 28, 2020. Severity: Moderate. Recall number: Z-0281-2021.
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