Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
| Source | FDA Device Enforcement |
|---|---|
| Category | Medical Device |
| Severity | Medium |
| Status | ongoing |
| Recall date | October 20, 2025 |
| Reported | November 26, 2025 |
| Recalling firm | Medtronic Perfusion Systems |
| Country / region | United States MN |
Hazard
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.
Affected products
- Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Related recalls
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