Reported Dec 25, 2019 · Terminated
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Medtronic Perfusion Systems
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Medtronic Perfusion Systems · 7611 Northland Dr N · Brooklyn Park, MN · 55428-1088
Is this the product you have?
Medtronic Affinity38um Arterial FilterCatalog number REF 351
- Lot codes and dates
- UDI 20643169858835
- Lot Numbers13316512
- Amount recalled
- 24 units
Where it was sold
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.
This product could cause temporary or reversible health problems — stop using it.
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