Device product
Halyard, EP LAB PK. Catalog Number: ESJH009-03.
Z-0927-2026
Product summary
- Event
- Event 98045
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 240 units
- Official record key
device-enforcement:Z-0927-2026
Official wording
Reason: Potential for incomplete seal on header bag.
Code information: Catalog Number: ESJH009-03. UDI-DI: 10809160427316. Lot Code: Lot Number: 1653112. Expiration Date: 5/28/2028.
Distribution pattern: US distribution to GA, IL, NE, MD.
Derived failure modes
-
Labeling or packaging
incomplete seal