[Recalled] CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas
Authorities recorded a safety problem with this product. The details below come directly from the government recall notice.
Recall details
| Product | CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. |
|---|---|
| Brand / manufacturer | Carefusion 211 Inc dba Carefusion |
| Category | device |
| Issuing authority | FDA_DEVICE |
| Reference | Z-1609-2015 |
| Country of notice | United States |
| Risk level | Class I |
| Hazard type | recall |
| Notice date | 03 April 2015 |
Why it was recalled
According to the FDA_DEVICE notice, the identified hazard is: A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.
This Class I recall concerns device products distributed in United States and was recorded by FDA_DEVICE. Recalls in this category are published so that owners, retailers, and importers can identify affected units and act quickly.
What to do if you own this product
Stop using the product immediately and follow the authority's remedy (return, repair, or disposal).
Read the full official notice →
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This page indexes a public government recall notice for reference. We do not sell or verify this product; always confirm the current status on the authority's official site.