Product Name: AVEA¿ Ventilator
Medical device recall Z-2273-2013. Published in FDA’s Enforcement Report on Oct 9, 2013.
- FDA Class I
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Oct 9, 2013. Copied from openFDA on Oct 20, 2026.
- Class I FDA’s most serious class (needs attention)
- Terminated its status, in FDA’s file
- Nationwide FDA’s word, and 1 state named
- 19,546 units how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class I, the most serious of FDA’s three classes.
“Dangerous or defective products that predictably could cause serious health problems or death. Examples include: food found to contain botulinum toxin, food with undeclared allergens, a label mix-up on a lifesaving drug, or a defective artificial heart valve.”
openFDA, in plain words, its enforcement report fields.
“Class I is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.”
FDA’s rule, 21 CFR 7.3(m)(1), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
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.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
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.
19,546 units, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
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…
Every code shown here, 1,999 characters
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 AKV01312 AKV01313 AKV01323 AKV01324 AKV01325 AKV01326 AKV01327 AKV01328 AKV01329 AKV01333 AKV01334 AKV01336 AKV01337 AKV01338 AKV01339 AKV01345 AKV01347 AKV01348 AKV01350 AKV01351 AKV01355 AKV01358 AKV01362 AKV01920 AKV01944 BAV04617 BAV04618 BAV04619 BAV04620 BAV04621 BAV04623 BAV04624 BAV04625 BAV04626 BAV04629 BAV04799 BAV04800 BAV04801 BAV04802 BAV04803 BBV01262 BBV01263 BBV01264 BBV01265 BBV01266 BBV01267 BBV01268 BBV01269 BBV01270 BBV01271 BBV03347 BBV03353 BBV03354 BBV03356 BBV03357 BBV03361 BBV03366 BBV03555 BBV03627 BBV03628 BBV03629 BBV03630 BBV03631 BBV03632 BBV03633 BBV03634 BBV03635 BBV03636 BBV03637 BBV03638 BBV03639 BBV03640 BBV03641 BBV03642 BBV03643 BBV03644 BBV03645 BBV03646 BBV03647 BBV03648 BBV03649 BBV03652 BBV03653 BBV03654 BBV03655 BBV03656 BBV03657 BBV03658 BBV03659 BBV03710 BBV03711 BBV03712 BCV02567 BCV02590 BCV02598 BCV02604 BCV02607 BCV02608 ACV01035 ACV01054 ACV01058 ACV01061 ACV01092 ACV01099 ACV01500 ACV01501 ACV01503 ACV01504 ACV01505 ACV01510 ACV01511 ACV01512 ACV01515 ACV01519 ACV01525 ACV01526 ACV01529 ACV01537 ACV01538 ACV01539 ACV01540 ACV01542…
FDA’s list runs to 643,157 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, American Samoa, Argentina, Australia, Austria, Bahrain, Barbados, Bangladesh, Belgium, Bermuda, Belize, Bolivia, Bosnia and Herzegovina, Brazil, Canada, Chile,China, Colombia, Costa Rica, Croatia, Cyprus, Czech Rep, Dominican Republic, Ecuador, Egypt, Estonia, El Salvador, Finland, France, Germany, Georgia, Greece, Guatemala, Hong Kong, Honduras, Hungary, India, Indonesia, Ireland, Israel, Italy, Japan, Jordan, Korea, Kuwait, Latvia, Lebanon, Lithuania, Lybia Jamahiriya, Malaysia, Mexico, Moldova, Morocco, Netherlands, Nepal, Nicaragua, Norway, Oman, Pakistan, Palastine, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Romania, Russian Federation, Rwanda, Saudi Arabia, Singapore, Slovenia, Slovakia, Spain, Switzerland, Taiwan, Thailand, Tunisia, Turkey, United Arab Emirates, and United Kingdom.
The states and territories these words name
- Puerto Rico
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
The words say it went outside the United States too.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Sep 5, 2013.
- FDA classified it on Sep 27, 2013.
- FDA’s Enforcement Report published it on Oct 9, 2013.
- FDA terminated it on Jun 4, 2015.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Carefusion 211 Inc dba Carefusion, of Yorba Linda, CA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 643,157 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.