International safety notice
Medical institutions in Japan have announced that it is difficult to pass the guide wire through the Luer connector of other catheters that use the same parts. A case has been reported. It turns out that it may contain. Therefore, we have decided to carry out a voluntary recall.
Japan / PMDA Recalls · JPN · Feb 1, 2024
Key facts
| Title | Medical institutions in Japan have announced that it is difficult to pass the guide wire through the Luer connector of other catheters that use the same parts. A case has been reported. It turns out that it may contain. Therefore, we have decided to carry out a voluntary recall. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: central circulatory system angiography catheter Brand name: Angiographic catheter |
| Manufacturer | Gadelius Medical Co., Ltd. |
| Models | CI-311F, 1015239 |
| Date | Feb 1, 2024 |
| 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