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.
Recall
- Recall Number
- Z-0281-2021
- Event Number
- 86351
- Firm
- Sobel Westex
- FEI Number
- 3003643727
- Product Code
- OEA
- Status
- Terminated
- Root Cause
- Nonconforming Material/Component
- Initiated
- August 13, 2020
- Terminated
- July 8, 2024
- Address
- 2670 Western Ave, Las Vegas, NV, 89109-1112
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.
Due to non-surgical isolation gowns not meeting all performance test requirements.
Customer Notification Letters titled "Voluntary Market Withdrawal - Customer Notification - SW-CMP0001" was sent out on 08/13/2020, 08/14/2020 and 08/25/2020 via email and telephone to a customer informing them that the Recalling Firm has become aware of non-surgical gowns labeled as Level 2 gowns do not meet the Level 2 requirements in one area of the gown. The Recalling Firm is instructing customers to: 1. Return any remaining affected gowns for a refund of the original purchase price, or 2. Return any remaining affected gowns and receive replacement of certified AAMI Level 2 isolated gowns at the Recalling Firm's expense. Customer are to contact Stan Levithan at 516-792-2152 to facilitate return and/or exchange of affected gowns.
U.S. Nationwide distribution including in the state of TN. O.U.S.: None
3,380,850 gowns