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.