FDA-Device2019-12-25Class II
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Hazard
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Sold states
CA
Affected count
24 units
Manufactured in
7611 Northland Dr N, Brooklyn Park, MN, United States
Products
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2020More Medtronic Perfusion Systems recalls
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