International safety notice
We received a message from a user of the product that the injection needle could not be used when cleaning and checking a new product before use. As a result, it was confirmed that a foreign object (metal fragment) had become stuck inside the injection needle. Is there a possibility that a similar event may occur with the same manufacturing lot as the product in question? We will collect the items voluntarily.
Japan / PMDA Recalls · JPN · Nov 1, 2023
Key facts
| Title | We received a message from a user of the product that the injection needle could not be used when cleaning and checking a new product before use. As a result, it was confirmed that a foreign object (metal fragment) had become stuck inside the injection needle. Is there a possibility that a similar event may occur with the same manufacturing lot as the product in question? We will collect the items voluntarily. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | General name: Recyclable injection needle Brand name: Atelocollagen injection needle |
| Manufacturer | Nagashima Medical Instruments Co., Ltd. |
| Models | Y12IF |
| Date | Nov 1, 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