Device product
Select Series Angled Tip Arterial Cannula, Model Number 72422 (22 Fr)
Z-0986-2025
Product summary
- Event
- Event 96015
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 440 units
- Official record key
device-enforcement:Z-0986-2025
Official wording
Reason: Incorrect labeling for seven manufactured lots of certain models of Arterial Cannulae.
Code information: Model 72422 UDI-DI: 20643169485970, Lot Numbers: 2023071075, 202309C075
Distribution pattern: Worldwide - US Nationwide distribution.
Derived failure modes
-
Labeling or packaging
Incorrect labeling