Device product
Halyard, Pain Pack. Kit Code: AMPK48-01.
Z-2407-2026
Product summary
- Event
- Event 99021
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 120 kits
- Official record key
device-enforcement:Z-2407-2026
Official wording
Reason: Inadvertent distribution of sealed pouches that had not undergone validated sterilization.
Code information: Kit Code: AMPK48-01. UDI-DI: 10809160472798. Lot Number: 334669. Expiration Date: 8/27/2028.
Distribution pattern: US Nationwide distribution in the state of Iowa.
Derived failure modes
-
Unknown
Inadvertent distribution of sealed pouches that had not undergone validated sterilization.