International safety notice
There are variations in the inner diameter dimensions in some processed parts of this product, and the inner diameter standard has not been met. We have received notification from a foreign manufacturer that there is a possibility that the product may come off, so we have decided to We will collect it voluntarily.
Japan / PMDA Recalls · JPN · Nov 24, 2021
Key facts
| Title | There are variations in the inner diameter dimensions in some processed parts of this product, and the inner diameter standard has not been met. We have received notification from a foreign manufacturer that there is a possibility that the product may come off, so we have decided to We will collect it voluntarily. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: central circulatory system tip transducer catheter Sales name: Optowire III |
| Manufacturer | Zeon Medical Co., Ltd. |
| Models | PG101, OW-3004D, OW-3003D, OW-3005D |
| Date | Nov 24, 2021 |
| 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