Device product
Halyard ORGAN RECOVERY OR PACK, Kit Code: LLOF1000-17.
Z-1001-2026
Product summary
- Event
- Event 98060
- Status
- Ongoing
- Classification
- Class I
- Quantity
- 52 units
- Official record key
device-enforcement:Z-1001-2026
Official wording
Reason: Devices are not suitable for organ transplant.
Code information: Kit Code: LLOF1000-17; UDI : 10809160460726, Lot No : 1651709
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.