International safety notice
A person with special approval for foreign-manufactured medical devices said, ``This is an option for the nitric oxide gas management system Ainoflow DS.'' In some batches of certain Check Valve Adapters, the valve may stick, blocking or reducing gas flow. We have received a report stating that we are conducting a recall as it has become clear that there is a possibility of We have confirmed that the check valve adapter has been shipped to the factory, so we will carry out a voluntary recall of the check valve adapter.
Japan / PMDA Recalls · JPN · Oct 16, 2023
Key facts
| Title | A person with special approval for foreign-manufactured medical devices said, ``This is an option for the nitric oxide gas management system Ainoflow DS.'' In some batches of certain Check Valve Adapters, the valve may stick, blocking or reducing gas flow. We have received a report stating that we are conducting a recall as it has become clear that there is a possibility of We have confirmed that the check valve adapter has been shipped to the factory, so we will carry out a voluntary recall of the check valve adapter. |
|---|---|
| Regulator | Japan / PMDA Recalls |
| Country | JPN |
| Brand | Common Name: Nitric Oxide Gas Management System Sales name: Ainoflow DS accessories and options |
| Manufacturer | Air Water Medical Co., Ltd. |
| Models | 74B2100237, 91346, 74L2001715, 74M2001125 |
| Date | Oct 16, 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