Z-0343-2023 Class II Ongoing

Recalled by Owens & Minor Distribution, Inc. — Mechanicsville, VA

Recall Details

Product Type
Devices
Report Date
December 7, 2022
Initiation Date
October 31, 2022
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
72 cases (2160 pouches)

Product Description

Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734

Reason for Recall

Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection

Distribution Pattern

IL, IN, WV

Code Information

UDI-DI: 10680651417340 Lot Number: AH1215T51