Device product
EOPA Arterial Cannula, Model Numbers 77422 (22 Fr) and 77418 (18 Fr)
Z-0985-2025
Product summary
- Event
- Event 96015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 930 units
- Official record key
device-enforcement:Z-0985-2025
Official wording
Reason: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Code information: Model 77418 UDI-DI: 20763000135618, Lot Numbers: 2022041038; Model 77422 UDI-DI: 20643169485970, Lot Number: 2023020934
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
Incorrect labeling