Medtronic Affinity recall
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Why was Medtronic Affinity recalled?
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
UDI 20643169858835, Lot Numbers: 13316512
- Product
- Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
- Recalling firm
- Medtronic Perfusion Systems
- Quantity
- 24 units
- Distribution
- CA
- Recall date
- December 25, 2019
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)