International safety notice
We have received a report from a medical institution that the effective length of the product in question is shorter than the indicated standard. As a result of our investigation, we found that for some products with serial numbers, the packaging labeling standard incorrectly indicated a guide wire of 150 cm for a product with an effective length of 180 cm. As it was discovered that the product was packaged, we will carry out a voluntary recall of the product with the relevant serial number.
Japan / PMDA Recalls · JPN · Jun 27, 2024
Key facts
| Title | We have received a report from a medical institution that the effective length of the product in question is shorter than the indicated standard. As a result of our investigation, we found that for some products with serial numbers, the packaging labeling standard incorrectly indicated a guide wire of 150 cm for a product with an effective length of 180 cm. As it was discovered that the product was packaged, we will carry out a voluntary recall of the product with the relevant serial number. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Cardiac/Central Circulatory System Catheter Guidewire Sales name: Good Tech Guide Wire |
| Manufacturer | Goodman Co., Ltd. |
| Models | 7538634, GWJ-32-180 |
| Date | Jun 27, 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