International safety notice
As a result of an internal investigation, we found that the component supplier's sterilization method for Terumo injection needles, which are the components of the kit, did not include gamma rays. It turned out that it had been changed to an electron beam. As it became clear that the combination was not possible, we decided to voluntarily recall the affected products that contain the components in question.
Japan / PMDA Recalls · JPN · Nov 5, 2021
Key facts
| Title | As a result of an internal investigation, we found that the component supplier's sterilization method for Terumo injection needles, which are the components of the kit, did not include gamma rays. It turned out that it had been changed to an electron beam. As it became clear that the combination was not possible, we decided to voluntarily recall the affected products that contain the components in question. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Single Use Class IV Treatment Kit Sales name: Urology kit |
| Manufacturer | Hogy Medical Co., Ltd. |
| Models | 227617339102, 1720454457 |
| Date | Nov 5, 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