International safety notice
In some Affinity Pixie oxygenator products, the raw materials used in the Luer connector differ from the approved specifications. We have decided to carry out a voluntary recall of products with specific lot numbers.
Japan / PMDA Recalls · JPN · Nov 11, 2021
Key facts
| Title | In some Affinity Pixie oxygenator products, the raw materials used in the Luer connector differ from the approved specifications. We have decided to carry out a voluntary recall of products with specific lot numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Extracorporeal membrane artificial lung Sales name: Affinity Pixie artificial lung |
| Manufacturer | Japan Medtronic Co., Ltd. |
| Models | BBP241, 13365773, 13383229, 13374060, 13373925, 13359644, 13383327 |
| Date | Nov 11, 2021 |
| Regulator page | info.pmda.go.jp |
At a glance
- No Recall
- No Field safety notice
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