Device product
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Z-0539-2026
Product summary
- Event
- Event 97912
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3850 units
- Official record key
device-enforcement:Z-0539-2026
Official wording
Reason: Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.
Code information: UDI/DI 20763000433844, Lot Number 232135734
Distribution pattern: US Nationwide distribution in the states of Hawaii and New York.
Derived failure modes
-
Unknown
Medtronic personnel observed trace amounts of dry blood on the external carton label and Instructions for Use (IFU) in five boxes of one lot of ACT Cartridges.