International safety notice
We have received reports that the adhesive on the tip of this product peeled off during surgery and the tip came off. We confirmed that there may have been insufficient adhesion to the tip. We have decided to carry out a voluntary recall of the lots in which this occurs.
Japan / PMDA Recalls · JPN · Sep 17, 2021
Key facts
| Title | We have received reports that the adhesive on the tip of this product peeled off during surgery and the tip came off. We confirmed that there may have been insufficient adhesion to the tip. We have decided to carry out a voluntary recall of the lots in which this occurs. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: aortic cannula Brand name: Extracorporeal circulation cannula Flexmate |
| Manufacturer | Senko Medical Industry Co., Ltd. |
| Models | ＣＯＫＮ‐Ｕ‐１３５, 203026, 212001 |
| Date | Sep 17, 2021 |
| Regulator page | info.pmda.go.jp |
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