International safety notice
Regarding this product, when connected to a Nipro pressure pump (hereinafter referred to as the "pump"), the air plug connection part We received a report of an incident where an air leak occurred and the bag was unable to inflate to the specified value due to inability to pressurize. As a result of an investigation by the manufacturer, the air plug that connects to the pump was incorrectly assembled in the wrong direction for products with certain serial numbers. It turns out that it's stuck. Therefore, we have decided to voluntarily recall all products with air plugs installed in the opposite direction.
Japan / PMDA Recalls · JPN · Oct 26, 2021
Key facts
| Title | Regarding this product, when connected to a Nipro pressure pump (hereinafter referred to as the "pump"), the air plug connection part We received a report of an incident where an air leak occurred and the bag was unable to inflate to the specified value due to inability to pressurize. As a result of an investigation by the manufacturer, the air plug that connects to the pump was incorrectly assembled in the wrong direction for products with certain serial numbers. It turns out that it's stuck. Therefore, we have decided to voluntarily recall all products with air plugs installed in the opposite direction. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common name: Manual pressure injection regulator Sales name: EN pressurized bag CS |
| Manufacturer | Nipro Co., Ltd. |
| Models | 26-268 |
| Date | Oct 26, 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