FDA-Device2025-11-26Class IIPACKAGING DEFECT
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
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.
Intended for
Adults
Illnesses reported
None reported
Sold states
US Nationwide distribution in the states of Hawaii and New York.
Affected count
3850 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic HR-ACT (High Range Activated Clotting Time Cartridges), REF 402-03
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0539-2026More Medtronic recalls
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