Device product
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
Z-0693-2020
Product summary
- Event
- Event 84410
- Status
- Terminated
- Classification
- Class II
- Quantity
- 24 units
- Official record key
device-enforcement:Z-0693-2020
Official wording
Reason: Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port.
Code information: UDI 20643169858835, Lot Numbers: 13316512
Distribution pattern: CA
Derived failure modes
-
Potency or specification failure
out of-specification