Device product
Halyard, ENT PACK. Model Number: JACK421-04. Convenience kit.
Z-2530-2025
Product summary
- Event
- Event 97452
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 57 units
- Official record key
device-enforcement:Z-2530-2025
Official wording
Reason: Potential for open header bag seals, compromising sterility.
Code information: Model Number: JACK421-04. UDI: 10809160462973. Lot Number: 1647218, Expiration Date: 7/17/2027.
Distribution pattern: US Nationwide distribution in the state of Florida.
Derived failure modes
-
Unknown
Potential for open header bag seals, compromising sterility.