International safety notice
We have received a report that there is a step at the tip when the dilator, which is a component of this product, is combined with the attached guide wire. Received from medical institution. As a result of our investigation, we found that some products with serial numbers were packaged with dilators whose inner diameters differed from the product specifications. We have decided to carry out a voluntary recall of products with the relevant serial numbers.
Japan / PMDA Recalls · JPN · May 9, 2024
Key facts
| Title | We have received a report that there is a step at the tip when the dilator, which is a component of this product, is combined with the attached guide wire. Received from medical institution. As a result of our investigation, we found that some products with serial numbers were packaged with dilators whose inner diameters differed from the product specifications. We have decided to carry out a voluntary recall of products with the relevant serial numbers. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Cardiac Catheter Introducer Kit Brand name: Goodtech Catheter Introducer |
| Manufacturer | Goodman Co., Ltd. |
| Models | CN240123HH, CN231108CH, N60BA16X, CN231222BH |
| Date | May 9, 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