Drug recall
CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to…
FDA recall event 70920 · Class I · Carefusion 211 Inc dba Carefusion
Key facts
| Event ID | 70920 |
|---|---|
| Recall numbers | Z-1609-2015 |
| Recalling firm | Carefusion 211 Inc dba Carefusion |
| Product type | Devices |
| Products | 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… |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Apr 3, 2015 |
| Report date | Jun 3, 2015 |
| Termination date | Jul 23, 2018 |
| City | Yorba Linda |
| State | CA |
| Country | United States |
| FEI number | 2050001 |
At a glance
- 1–9 Products in this recall
- None FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: