Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Reported: November 26, 2025 Initiated: October 20, 2025 #Z-0539-2026
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.
Details
- Recalling Firm
- Medtronic Perfusion Systems
- Units Affected
- 3850 units
- Distribution
- US Nationwide distribution in the states of Hawaii and New York.
- Location
- Brooklyn Park, MN
Frequently Asked Questions
What product was recalled? ▼
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03. Recalled by Medtronic Perfusion Systems. Units affected: 3850 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 26, 2025. Severity: Moderate. Recall number: Z-0539-2026.
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