International safety notice
Although this product requires approval as a Class II controlled medical device, the generic name has been changed to “single-use”. The product was manufactured and sold as a Class I medical device as an "electrode cleaner". We decided to mainly collect it.
Japan / PMDA Recalls · JPN · Aug 29, 2024
Key facts
| Title | Although this product requires approval as a Class II controlled medical device, the generic name has been changed to “single-use”. The product was manufactured and sold as a Class I medical device as an "electrode cleaner". We decided to mainly collect it. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Single use electrode クリーナ Sales name: Carbotect |
| Manufacturer | Adachi Co., Ltd. |
| Models | 1122129, 0623161, EL101 |
| Date | Aug 29, 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