[pending] Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Pending LLM rewrite. Source: FDA_DEVICE Z-0539-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
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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