FDA Device recall Z-1609-2015
CareFusion AVEA ventilator, all models
- FDA Device
- Class I
- terminated
- Published 2015-06-03
On 2015-06-03 the FDA classified a Class I recall of CareFusion AVEA ventilator, all models by Carefusion 211, citing 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 vent….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1609-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2015-04-03 |
| Published | 2015-06-03 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 211 |
| Distribution | US |
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.
Reason
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.
Identifiers
| code_info | Serial No. AKV01874 AGV01443 AEV02197 AKV02580 AEV02375 BBV01304 BBV01303 AJV02510 AJV02502 AGV0265…Serial No. AKV01874 AGV01443 AEV02197 AKV02580 AEV02375 BBV01304 BBV01303 AJV02510 AJV02502 AGV02650 AFV01802 AFV01792 AFV01400 AFV01361 AEV01622 AEV01608 AKV01915 BBV03730 BBV03557 BBV03556 BBV03554 BBV03553 BBV 3558 BBV01406 BBV01396 AHV01880 AGV02205 BBV01432 AFV01657 AFV01655 AFV01647 BAV05234 AHV03069 AGV02249 BBV03797 BAV06514 BDV01011 BDV01000 BCV01938 BAV04011 BAV04010 BAV04009 BAV04005 BAV04004 BAV04003 BAV04002 BAV01313 AKV04053 AJV02289 BAV04021 AEV02264 AEV02225 AEV02205 ADV06091 AKV02569 AHV01206 AKV04351 AKV04349 AKV02550 AGV01385 AHV03128 ADV04116 BBV06059 BBV06057 BAV05153 AFV01492 BBV01620 BDV01371 BAV06447 BAV06446 BAV06445 AEV01724 AEV01712 BAV06463 AEV01694 AJV02446 AGV02139 BAV04188 BAV04187 AKV01153 AKV01147 AEV02720 AEV02717 AEV02713 BAV0 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1609-2015%22
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