Z-0693-2020 Class II Terminated
FDA device recall Z-0693-2020 was initiated by Medtronic Perfusion Systems on November 14, 2019 and is designated Class II. Reason for recall: Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port. The recall status is terminated (terminated October 5, 2020). Affected quantity: 24 units.
Recall Details
- Product Type
- Devices
- Report Date
- December 25, 2019
- Initiation Date
- November 14, 2019
- Termination Date
- October 5, 2020
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 24 units
Product Description
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 Pattern
CA
Code Information
UDI 20643169858835, Lot Numbers: 13316512