International safety notice
In the manufacturing lot of the product in question, an intermediate inspection found that "a needle is stuck in the primary packaging (hard case)" (hereinafter referred to as This event) was discovered. It was recognized that this may be due to the operation after restarting after a pause. The lot subject to recall (hereinafter referred to as this lot) has a different manufacturing period from the lot in production where this event occurred, but Since we cannot deny that this has occurred, we have decided to voluntarily recall the product.
Japan / PMDA Recalls · JPN · Jun 11, 2021
Key facts
| Title | In the manufacturing lot of the product in question, an intermediate inspection found that "a needle is stuck in the primary packaging (hard case)" (hereinafter referred to as This event) was discovered. It was recognized that this may be due to the operation after restarting after a pause. The lot subject to recall (hereinafter referred to as this lot) has a different manufacturing period from the lot in production where this event occurred, but Since we cannot deny that this has occurred, we have decided to voluntarily recall the product. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Single use injection needle Sales name: TSK Stereject LDS |
| Manufacturer | Task Co., Ltd. |
| Models | LDS-25025T-J100, 209097 |
| Date | Jun 11, 2021 |
| 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