Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
This recall has been terminated (originally issued November 14, 2019).
- Company
- Medtronic Perfusion Systems
- Recall Initiated
- November 14, 2019
- Terminated
- October 5, 2020
- Recall Number
- Z-0693-2020
- Quantity
- 24 units
- Firm Location
- Brooklyn Park, MN
- Official Source
- View on FDA website ↗
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
Lot / Code Info
UDI 20643169858835, Lot Numbers: 13316512
Root Cause
Process control
Action Taken
Beginning 14-Nov-2019, Medtronic initiated an immediate Urgent Medical Device Recall via verbal communication to one (1) customer that was shipped the affected product according to Medtronic records. The customer was asked to identify and quarantine any unused affected product. The immediate communication was followed by a written urgent medical device recall notification beginning on 26-Nov-2019 to communicate the issue to the one (1) customer that received affected product. The consignee was asked to confirm receipt of urgent medical device recall notification via a Customer Confirmation Certificate. Medtronic is seeking the return of the affected product.