International safety notice
It contained a monitoring tube connector made of a material different from that stated in the approval letter. As a result, we have decided to voluntarily recall the products with the lot number.
Japan / PMDA Recalls · JPN · Aug 7, 2023
Key facts
| Title | It contained a monitoring tube connector made of a material different from that stated in the approval letter. As a result, we have decided to voluntarily recall the products with the lot number. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Angiography kit Sales name: Disposable angio kit |
| Manufacturer | Sugan Co., Ltd. |
| Models | H2648135, H2642207, MM2199, MS3215-A, H2654487, MS3187, H2642229, H2653444, H2648129, H2644497, H2654486, H2665603 and 15 more |
| Date | Aug 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