International safety notice
For the target products, a legal display label is affixed at the originally registered manufacturing facility, and the product is released on the market after receiving a shipping decision. Where it should be shipped, it is shipped without going through a manufacturing facility, without a legal label attached, and without a shipping determination. We are conducting a voluntary recall as we have discovered that this has been done.
Japan / PMDA Recalls · JPN · Jun 15, 2023
Key facts
| Title | For the target products, a legal display label is affixed at the originally registered manufacturing facility, and the product is released on the market after receiving a shipping decision. Where it should be shipped, it is shipped without going through a manufacturing facility, without a legal label attached, and without a shipping determination. We are conducting a voluntary recall as we have discovered that this has been done. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Artificial heart valve sizer Sales name: Artificial heart valve sizer set |
| Manufacturer | Corcym Japan Co., Ltd. |
| Models | 2304180038, VS-200 |
| Date | Jun 15, 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