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Medtronic Perfusion Systems: Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03

Medical DevicesSource: FDA (device) · Date: 2025-11-26

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The text below is copied from the official FDA (device) record. If anything differs, the official notice is correct.

Company / brand
Medtronic Perfusion Systems
Product
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Reason / 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.
Classification
Class II
Status
Ongoing
Distribution / sold at
US Nationwide distribution in the states of Hawaii and New York.
Recall initiated
2025-10-20
Code info
UDI/DI 20763000433844, Lot Number 232135734
Product quantity
3850 units
Voluntary mandated
Voluntary: Firm initiated
City
Brooklyn Park
State
MN
Country
United States
Event id
97912
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