FDA Enforcement
Class II
Ongoing
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Recall: Z-0539-2026
·
Reported November 26, 2025
Enforcement
- Recall Number
- Z-0539-2026
- Event ID
- 97912
- Classification
- Class II
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Medtronic Perfusion Systems
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- November 26, 2025
- Initiation Date
- October 20, 2025
- Classification Date
- November 18, 2025
- Address
- 7611 Northland Dr N, Brooklyn Park, MN, 55428-1088, United States
Description
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
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 Info
UDI/DI 20763000433844, Lot Number 232135734
Distribution
US Nationwide distribution in the states of Hawaii and New York.
Quantity
3850 units