International safety notice
We have been informed by the market that there is a discrepancy between the catalog and the secondary packaging box label. As a result of investigating the records, it was discovered that there was an error in the shaft length description on the box label of the secondary packaging, so a voluntary review was conducted. We have decided to collect the proceeds.
Japan / PMDA Recalls · JPN · Aug 12, 2022
Key facts
| Title | We have been informed by the market that there is a discrepancy between the catalog and the secondary packaging box label. As a result of investigating the records, it was discovered that there was an error in the shaft length description on the box label of the secondary packaging, so a voluntary review was conducted. We have decided to collect the proceeds. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Reinforced tracheostomy tube for ventilation Brand name: MRI Silver Spiral Intratracheostomy Tube |
| Manufacturer | Fuji Systems Co., Ltd. |
| Models | FR-12, 0204202, 2203927 |
| Date | Aug 12, 2022 |
| 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