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Medtronic Perfusion Systems recalls Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Recalled December 25, 2019 · FDA recall Z-0693-2020 · Medtronic Perfusion Systems
Hazard
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port. · FDA Class II
Units
24 units
Sold at
CA
Description
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Product
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Manufacturer(s)
Medtronic Perfusion Systems
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →