Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Pending LLM rewrite. Source: FDA_DEVICE Z-0539-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- Product
- Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
- Manufacturer
- Medtronic Perfusion Systems
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- UDI/DI 20763000433844
- Lot Number 232135734
Distribution
Distributed nationwide across the United States.
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