International safety notice
An overseas manufacturing facility sent a message saying, ``The hemostasis valve (Y connector), which is a component of the kit (hereinafter referred to as the component). Regarding this, we received a report from the public that the guide wire was difficult to pass through the component manufactured after changing the mold. "We have decided to voluntarily recall the relevant components and the kits containing them." I have been contacted.
Japan / PMDA Recalls · JPN · Mar 7, 2022
Key facts
| Title | An overseas manufacturing facility sent a message saying, ``The hemostasis valve (Y connector), which is a component of the kit (hereinafter referred to as the component). Regarding this, we received a report from the public that the guide wire was difficult to pass through the component manufactured after changing the mold. "We have decided to voluntarily recall the relevant components and the kits containing them." I have been contacted. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Angiography kit Sales name: Disposable PTCA kit |
| Manufacturer | Sugan Co., Ltd. |
| Models | YP114, H2275990, YS055-A, H2258787, H2284956, YS018, YP002, H2269321 |
| Date | Mar 7, 2022 |
| 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