FDA Device recall Z-0693-2020
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
- FDA Device
- Class II
- terminated
- Published 2019-12-25
On 2019-12-25 the FDA classified a Class II recall of Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 by Medtronic Perfusion Systems, citing medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0693-2020 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-11-14 |
| Published | 2019-12-25 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Medtronic Perfusion Systems |
| Distribution | CA |
Product
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Reason
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Identifiers
| code_info | UDI 20643169858835, Lot Numbers: 13316512 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0693-2020%22
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