FDA-Device2020-07-15Class II
Extra corporeal circuit with bio-active surface.
Hazard
Affected products failed a sterilization test.
Sold states
Domestic Distribution only to CA and MI.
Affected count
10 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Extra corporeal circuit with bio-active surface.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2495-2020More Medtronic Perfusion Systems recalls
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