FDA Device recall Z-2273-2013
Product Name: AVEA¿ Ventilator
- FDA Device
- Class I
- terminated
- Published 2013-10-09
On 2013-10-09 the FDA classified a Class I recall of Product Name: AVEA¿ Ventilator by Carefusion 211, citing careFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pres….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-2273-2013 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2013-09-05 |
| Published | 2013-10-09 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Carefusion 211 |
| Distribution | US |
Product
Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Reason
CareFusion has identified a potential risk associated with AVEA¿ ventilators when used at higher altitudes. A proactive complaint review identified an error in the barometric pressure compensation. CareFusion is voluntarily initiating a field correction of the affected devices to correct the error.
Identifiers
| code_info | All Models. Serial Numbers: BCV01807 AEV01754 AFV01269 AFV01692 AFV01694 AFV02330 AFV02338 AFV02339 AFV0234…All Models. Serial Numbers: BCV01807 AEV01754 AFV01269 AFV01692 AFV01694 AFV02330 AFV02338 AFV02339 AFV02349 AFV02350 AFV02515 AGV01817 AGV01818 AGV02135 AGV02189 AGV02296 AGV02306 AGV02344 AHV03372 AJV01001 AJV01242 AJV01292 AJV01297 AJV01300 AJV01301 AJV01701 AJV01702 AJV01703 AJV01716 AJV01718 AJV01732 AJV01733 AJV01746 AJV01748 AJV01749 AJV01819 AJV01820 AJV01824 AJV02086 AJV02088 AJV02089 AJV02090 AJV02091 AJV02093 AJV02097 AJV02099 AJV02208 AJV02306 AJV02311 AJV02320 AJV02321 AJV02322 AJV02323 AJV02324 AJV02325 AJV02326 AJV02327 AJV02328 AJV02329 AJV02330 AJV02331 AJV02332 AJV02333 AJV02334 AJV02335 AJV02337 AJV02338 AJV02341 AJV02342 AJV02343 AJV02344 AJV02345 AJV02346 AJV02347 AJV02349 AJV02350 AJV02351 AJV02352 AJV02353 AJV02354 AJV02355 AJV02356 AJV02357 AJV02358 AJV02359 AJV02965 AKV01257 AKV01272 AKV01303 AKV01304 AKV01305 AKV01306 AKV01307 AKV01308 AKV01309 AKV01310 AKV01311 |
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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-2273-2013%22
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