International safety notice
Urgent Field Safety Notice for Affinity Pixie Oxygenator und Kardiotomiereservoir / venöses Reservoir mit Balance Biosurface und Perfusionsschlauchsets mit dem betroffenen Affinity by Medtronic Inc
Germany / BfArM · DEU · Feb 9, 2021
Key facts
| Title | Urgent Field Safety Notice for Affinity Pixie Oxygenator und Kardiotomiereservoir / venöses Reservoir mit Balance Biosurface und Perfusionsschlauchsets mit dem betroffenen Affinity by Medtronic Inc |
|---|---|
| Regulator | Germany / BfArM |
| Country | DEU |
| Brand | Affinity Pixie Oxygenator und Kardiotomiereservoir / venöses Reservoir mit Balance Biosurface und Perfusionsschlauchsets mit dem betroffenen Affinity |
| Manufacturer | Medtronic Inc |
| Models | 13347907, 13339133, 13353701, 220911913, FA955, 13348521, M483203D, 13352832, 13353800, 220906731, 13340766, 13340434 and 47 more |
| Date | Feb 9, 2021 |
| Regulator page | bfarm.de |
At a glance
- No Recall
- No Field safety notice
- 1–9 Matching device models in FDA data
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About International device safety notices
Field safety notices, recalls and safety alerts published by about 30 national medical device regulators outside the United States, matched by Orca1 to FDA device data.
Source: National medical device regulators (as listed), compiled by Orca1