International safety notice
Although the product should have been approved as a controlled medical device, it was notified and sold as a general medical device, so the product cannot be recalled. That's what I said.
Japan / PMDA Recalls · JPN · Dec 28, 2021
Key facts
| Title | Although the product should have been approved as a controlled medical device, it was notified and sold as a general medical device, so the product cannot be recalled. That's what I said. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Gas pressure suction device Sales name: Biggar 2020 |
| Manufacturer | Ingex Japan Co., Ltd. |
| Models | R2No27 |
| Date | Dec 28, 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