Recall Z-0693-2020 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Medtronic Perfusion Systems
Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351
| Date | Nov 14, 2019 |
| Status | Terminated |
| Reason | Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port. |
| Root cause | Process control |
| Action | 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 Ce |
| Quantity | 24 units |
| Distribution | CA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K952532 | AFFINITY ARTERIAL BLOOD FILTER Avecor Cardiovascular, Inc., Oct 6, 1995 |