International safety notice
An incident occurred in which a biopsy instrument could not be inserted due to the inclusion of a product in which the inner diameter of the outer cylinder needle was smaller than the specification. We have received notification from an overseas manufacturer that this has occurred, so we have decided to carry out a voluntary recall of a specific lot (manufacturing number) of products. did.
Japan / PMDA Recalls · JPN · Mar 27, 2023
Key facts
| Title | An incident occurred in which a biopsy instrument could not be inserted due to the inclusion of a product in which the inner diameter of the outer cylinder needle was smaller than the specification. We have received notification from an overseas manufacturer that this has occurred, so we have decided to carry out a voluntary recall of a specific lot (manufacturing number) of products. did. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single use needle for tissue production Sales name: MISSION core needle |
| Manufacturer | Medicon Co., Ltd. |
| Models | 1816MSK, 0001450414, 0001453517, 0001447513 |
| Date | Mar 27, 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