Device product
Halyard, MIDTOWN GENERAL ARTERIOGRAM. Catalog Number: EUHM009-01.
Z-0928-2026
Product summary
- Event
- Event 98045
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 300 units
- Official record key
device-enforcement:Z-0928-2026
Official wording
Reason: Potential for incomplete seal on header bag.
Code information: Catalog Number: EUHM009-01. UDI-DI: 10809160346839. Lot Number: 1635477. Expiration Date: 5/29/2028.
Distribution pattern: US distribution to GA, IL, NE, MD.
Derived failure modes
-
Labeling or packaging
incomplete seal