Las Vegas, NV, United States
Sobel Westex recalls
1 recall recorded since 2018, most recently on 13 August 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 13 August 2020
- Terminated
- 8 July 2024
- Reason
- 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
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-0281-2021
- 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 relativ
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.