Device product
Halyard, HEAD AND NECK TRAY. Catalog Number: EURO016-09.
Z-0930-2026
Product summary
- Event
- Event 98045
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 56 units
- Official record key
device-enforcement:Z-0930-2026
Official wording
Reason: Potential for incomplete seal on header bag.
Code information: Catalog Number: EURO016-09. UDI-DI: 10809160461198. Lot Number: 1655501 Expiration Date: 3/31/2027.
Distribution pattern: US distribution to GA, IL, NE, MD.
Derived failure modes
-
Labeling or packaging
incomplete seal