Device product
Halyard MINI PLUS KIT SOUTH, Kit Code: JACK097-08
Z-1002-2026
Product summary
- Event
- Event 98060
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 380 units
- Official record key
device-enforcement:Z-1002-2026
Official wording
Reason: Devices are not suitable for organ transplant.
Code information: Kit Code: JACK097-08; UDI : 10809160462829; Lot No: 1654185.
Distribution pattern: US Nationwide distribution in the states of FL, GA and Puerto Rico.
Derived failure modes
-
Unknown
Devices are not suitable for organ transplant.