International safety notice
For the target product, we applied for partial change approval to add a manufacturing site, but the manufacturing site that was scheduled to be added before the approval was obtained. After 15 units of products manufactured at the site arrived in Japan, it was confirmed that 2 units had been shipped. We have decided to carry out a voluntary recall of the product with (serial number).
Japan / PMDA Recalls · JPN · Oct 20, 2023
Key facts
| Title | For the target product, we applied for partial change approval to add a manufacturing site, but the manufacturing site that was scheduled to be added before the approval was obtained. After 15 units of products manufactured at the site arrived in Japan, it was confirmed that 2 units had been shipped. We have decided to carry out a voluntary recall of the product with (serial number). |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Catheter for penetrating vascular stenosis Brand name: SEEKER support catheter |
| Manufacturer | Medicon Co., Ltd. |
| Models | 93PH0101, SK13535M |
| Date | Oct 20, 2023 |
| 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