Device recall: Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on…
Class I FDA enforcement event 66219. Recall start date: . Status in the FDA record: Terminated. Termination date: .
Reason for recall, in the words of FDA
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.
Class I, in the words of FDA
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
Carefusion 211 Inc dba Carefusion started this device recall on 5 Sep 2013. The firm address in the FDA record is in Yorba Linda, CA. FDA put the recall in Class I. FDA event 66219 has 1 product record. The first FDA enforcement report date is 9 Oct 2013. The record gives the status Terminated, with the termination date 4 Jun 2015.
It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on . openFDA export of .
Distribution
In the words of FDA.
Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, American Samoa, Argentina, Australia, Austria, Bahrain, Barbados, Bangladesh, Belgium, Bermuda, Belize,…
Recalling firm
Carefusion 211 Inc dba Carefusion, Yorba Linda, CA.
Recalling firm: The firm that the FDA record names for a recall.
FDA records how the recall started: Voluntary: Firm initiated.
Products
1 product record in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2273-2013 | 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… | 19,546 units | Class I | Terminated | 9 Oct 2013 |
openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports.
Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.
Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.
Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.
Class I: The highest of the three FDA recall classes.
The event in context
- Device events that started in 2013
- 1,236
- Share of these events in Class I
- 6%
- Product records in this event
- 1Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 17 May 2016 | AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist | Device | Class I | 12 |
| 3 Apr 2015 | CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically co | Device | Class I | 1 |
Official channels
- FDA enforcement report Z-2273-2013The FDA record of the first product of this event.
- FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
- FDA MedWatchThe FDA safety reporting program for drugs and medical devices.
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Cite this page
Recall Register. FDA enforcement event 66219. https://recallregister.com/fda/i/66219/. Source: openFDA enforcement reports. Data through .
Sources
- Source
- openFDA device enforcement reports
- Licence
- CC0 1.0
- Export date
- 28 Sep 2026
- Newest FDA report date on the register
- 23 Sep 2026
FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.
Questions
- Where was the product distributed?
- The FDA record gives this distribution:
Worldwide distribution: US (nationwide) including Puerto Rico and countries of: Albania, American Samoa, Argentina, Australia, Austria, Bahrain, Barbados, Bangladesh, Belgium, Bermuda, Belize,…
- What quantity of product is in FDA event 66219?
- The FDA record gives this quantity:
19,546 units
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2013 have the same class?
- 6% of the 1,236 device events that started in 2013 are in Class I.