International safety notice
An overseas manufacturer has stated that when the user presses the trigger of this product outside the body to check its operation, the cannula may become bogged down. I was informed that I may be removed from the program. We have decided to implement the following.
Japan / PMDA Recalls · JPN · Aug 18, 2022
Key facts
| Title | An overseas manufacturer has stated that when the user presses the trigger of this product outside the body to check its operation, the cannula may become bogged down. I was informed that I may be removed from the program. We have decided to implement the following. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single use needle for tissue production Brand name: Merit Corboset Biopsy System |
| Manufacturer | Merit Medical Japan Co., Ltd. |
| Models | I2093995, I2127521, H1782158, H1808042, H1807721, H1815597, I2116109, I2283710, I2170247, CORA1615, H1462686, H1776075 and 130 more |
| Date | Aug 18, 2022 |
| 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