Device recall: AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or…
Class I FDA enforcement event 74111. 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 Ventilator caused by an incorrect F1 fuse on the AVEA Ventilator Transducer Communication Alarm (TCA) Board which may fail/blow, causing loss of power to the User Interface Module (UIM).
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 17 May 2016. The firm address in the FDA record is in Yorba Linda, CA. FDA put the recall in Class I. FDA event 74111 has 12 product records. The first FDA enforcement report date is 22 Jun 2016. The record gives the status Terminated, with the termination date 28 Sep 2017.
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) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan,…
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
12 product records in the event.
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-1888-2016 | AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1889-2016 | AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1890-2016 | AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1891-2016 | AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1892-2016 | AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1893-2016 | AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1894-2016 | TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1895-2016 | Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1896-2016 | Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1897-2016 | Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1898-2016 | AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
| Z-1899-2016 | AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. | 922 units total (501 units in US) | Class I | Terminated | 22 Jun 2016 |
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 2016
- 1,232
- Share of these events in Class I
- 3%
- Product records in this event
- 12Median of the firm: 1
- Events of the firm on the register
- 3
Other events of the firm
| Initiated | Product (first record) | Type | Class | Records |
|---|---|---|---|---|
| 3 Apr 2015 | CareFusion AVEA ventilator, all models. Product Usage: A continuous ventilator (respirator), intended to mechanically co | Device | Class I | 1 |
| 5 Sep 2013 | Product Name: AVEA Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05 | Device | Class I | 1 |
Official channels
- FDA enforcement report Z-1888-2016The 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.
Follow by RSS:Food, drug and device recallsFDA Class I recalls
Cite this page
Recall Register. FDA enforcement event 74111. https://recallregister.com/fda/i/74111/. 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) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan,…
- What quantity of product is in FDA event 74111?
- The event has 12 product records. The first record gives this quantity:
922 units total (501 units in US)
- How did the recall start?
- The FDA record says:
Voluntary: Firm initiated
- How many device recalls of 2016 have the same class?
- 3% of the 1,232 device events that started in 2016 are in Class I.