FDA recall Z-0693-2020
Medtronic Perfusion Systems · Class II · device
Product
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Reason for recall
Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Distribution
CA
Key facts
- Status
- Terminated
- Initiation date
- 2019-11-14
- Report date
- 2019-12-25
- Termination date
- 2020-10-05
- Voluntary/Mandated
- Voluntary: Firm initiated
- Location
- Brooklyn Park, MN, United States
Primary source
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0693-2020