Recall Z-0281-2021 ยท OEA Non-Surgical Gown
Sobel Westex
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.
| Date | Aug 13, 2020 |
| Status | Terminated |
| Reason | Due to non-surgical isolation gowns not meeting all performance test requirements. |
| Root cause | Nonconforming Material/Component |
| Action | 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 gown |
| Quantity | 3,380,850 gowns |
| Distribution | U.S. Nationwide distribution including in the state of TN. O.U.S.: None |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.