International safety notice
This device is used by attaching it to a portable or in-hospital oxygen cylinder. Two cases were confirmed during the production process where the fixing screw broke and the dial came off the main body along with the shaft. As a result, the screw breakage occurred from the same lot of screws that were put into the manufacturing process at the manufacturer around November 2020. It turns out that. We have confirmed that this is the case. However, it is less than 1/20 of the load required when tightening screws during manufacturing at the manufacturer, and there is no need to remove the dial during the production process. We believe that we have been able to detect any defects before they are released to the market because we are removing them and adjusting the flow rate settings. To date, we have not received any information from the market regarding the occurrence of this defect, but we have completely ruled out the possibility of it occurring in the future. Since it cannot be determined, it will be collected.
Japan / PMDA Recalls · JPN · May 2, 2024
Key facts
| Title | This device is used by attaching it to a portable or in-hospital oxygen cylinder. Two cases were confirmed during the production process where the fixing screw broke and the dial came off the main body along with the shaft. As a result, the screw breakage occurred from the same lot of screws that were put into the manufacturing process at the manufacturer around November 2020. It turns out that. We have confirmed that this is the case. However, it is less than 1/20 of the load required when tightening screws during manufacturing at the manufacturer, and there is no need to remove the dial during the production process. We believe that we have been able to detect any defects before they are released to the market because we are removing them and adjusting the flow rate settings. To date, we have not received any information from the market regarding the occurrence of this defect, but we have completely ruled out the possibility of it occurring in the future. Since it cannot be determined, it will be collected. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: High pressure gas regulator Brand name: Flow rate setting device TR |
| Manufacturer | Teijin Pharma Co., Ltd. |
| Models | 2350C83335, 2349C83253, 2407C83503, 2349C83081, 2345C82607, 2348C82957, 2345C82611, 2349C83232, 2346C82809, 2345C82503, 2348C83050, 2344C82372 and 1249 more |
| Date | May 2, 2024 |
| 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