International safety notice
It has been found that for devices that have been manufactured for more than three years, there is a possibility that the expander body may be damaged due to aging. did. Therefore, we have decided to recall products that are within the expiration date and three years after manufacture.
Japan / PMDA Recalls · JPN · Jun 22, 2023
Key facts
| Title | It has been found that for devices that have been manufactured for more than three years, there is a possibility that the expander body may be damaged due to aging. did. Therefore, we have decided to recall products that are within the expiration date and three years after manufacture. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Urinary tract use カテーテル Brand name: Uropas ureteral access sheath |
| Manufacturer | Olympus Medical Systems Co., Ltd. |
| Models | 09B1900184, 09D1900118, 61224BX, 61254BX, 61338BX, 61138BX, 61246BX, 61324BX, 61238BX, 61346BX, 61046BX, 61038BX and 3 more |
| Date | Jun 22, 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