Z-0539-2026 Class II Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- November 26, 2025
- Initiation Date
- October 20, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 3850 units
Product Description
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Reason for Recall
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.
Distribution Pattern
US Nationwide distribution in the states of Hawaii and New York.
Code Information
UDI/DI 20763000433844, Lot Number 232135734