International safety notice
After researching overseas manufacturers, we found that different sizes of outer needles (coaxial needles) were included in the kit, and that the inner diameter of the outer needle The biopsy needle cannot be inserted because the needle is thinner than the specifications, or the inner diameter of the outer cylinder needle is thicker than the specifications, or the needle length is too long. It was discovered that the biopsy needle was not compatible with the external needle due to its length, and there was a possibility that tissue biopsy could not be performed. We have decided to carry out a voluntary recall of this product.
Japan / PMDA Recalls · JPN · Dec 7, 2023
Key facts
| Title | After researching overseas manufacturers, we found that different sizes of outer needles (coaxial needles) were included in the kit, and that the inner diameter of the outer needle The biopsy needle cannot be inserted because the needle is thinner than the specifications, or the inner diameter of the outer cylinder needle is thicker than the specifications, or the needle length is too long. It was discovered that the biopsy needle was not compatible with the external needle due to its length, and there was a possibility that tissue biopsy could not be performed. We have decided to carry out a voluntary recall of this product. |
|---|---|
| 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 | 0001456596, 0001490108, 0001418637, 1467088, 0001440545, 0001414700, 0001492487, 497925, 0001412040, 0001478968, 2016MSK, 0001402164 and 98 more |
| Date | Dec 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