International safety notice
The manufacturer has found a vulnerability in some of the products in the target lot, and the physiological saline used in conjunction with the product may leak from the product during use. We have decided to voluntarily recall all affected lots that have already been shipped. Ta.
Japan / PMDA Recalls · JPN · Nov 7, 2023
Key facts
| Title | The manufacturer has found a vulnerability in some of the products in the target lot, and the physiological saline used in conjunction with the product may leak from the product during use. We have decided to voluntarily recall all affected lots that have already been shipped. Ta. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Hydraulic knife (active instrument for radiofrequency treatment) Sales name: Elbe JET2 Pump Cartridge Plus |
| Manufacturer | Amco Co., Ltd. |
| Models | WO403038 |
| Date | Nov 7, 2023 |
| 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