Device product
Aero Blue Performance Surgical Gown, XL- Sterile surgical gown Code: 41734
Z-0343-2023
Product summary
- Event
- Event 91122
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 72 cases (2160 pouches)
- Official record key
device-enforcement:Z-0343-2023
Official wording
Reason: Potential open seal pouches compromising sterility resulting in the use of a non-sterile product in surgery could lead to patient infection
Code information: UDI-DI: 10680651417340 Lot Number: AH1215T51
Distribution pattern: IL, IN, WV
Derived failure modes
-
Labeling or packaging
open seal