Z-0343-2023 Class II Ongoing
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