Medtronic Perfusion Systems recalls Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
- Recall date
- November 14, 2019
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-0693-2020
- FDA classification
- Class II
- Brand / firm
- Medtronic Perfusion Systems
- Sold / distributed
- CA
Why it was recalled
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
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