International safety notice
Due to a defect in the manufacturing process of a foreign manufacturer, the heat treatment process of the heat shrink tube was incorrect for some products in the lot. It turns out that it may not have been implemented. We decided to collect the heat shrink tube because it may not shrink completely and may fall off during use.
Japan / PMDA Recalls · JPN · Nov 12, 2024
Key facts
| Title | Due to a defect in the manufacturing process of a foreign manufacturer, the heat treatment process of the heat shrink tube was incorrect for some products in the lot. It turns out that it may not have been implemented. We decided to collect the heat shrink tube because it may not shrink completely and may fall off during use. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Endoscopic active instrument for single-use radiofrequency procedures Sales name: Microline Renew Series |
| Manufacturer | Amco Co., Ltd. |
| Models | 0811099010036, 00172110, M370012 |
| Date | Nov 12, 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