Device product
Halyard, GENERAL LAPAROSCOPY PACK. Catalog Number: VAST018-10.
Z-0926-2026
Product summary
- Event
- Event 98045
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 42 units
- Official record key
device-enforcement:Z-0926-2026
Official wording
Reason: Potential for incomplete seal on header bag.
Code information: Catalog Number: VAST018-10. UDI-DI: 10809160452257. Lot Number: 1651776. Expiration Date: 3/12/2027
Distribution pattern: US distribution to GA, IL, NE, MD.
Derived failure modes
-
Labeling or packaging
incomplete seal