Device product
Halyard, MAJOR PACK. Catalog Number: JEMJ10-01.
Z-0929-2026
Product summary
- Event
- Event 98045
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 90 units
- Official record key
device-enforcement:Z-0929-2026
Official wording
Reason: Potential for incomplete seal on header bag.
Code information: Catalog Number: JEMJ10-01. UDI-DI: 10809160443217. Lot Number: 1635770. Expiration Date: 7/26/2027.
Distribution pattern: US distribution to GA, IL, NE, MD.
Derived failure modes
-
Labeling or packaging
incomplete seal