Carefusion 211 Inc dba Carefusion

FDA recalling firm · 3 enforcement events · 14 product records · 2013–2016 · CA

Carefusion 211 Inc dba Carefusion has 3 FDA enforcement events on this register (14 product records) between 2013 and 2016: 3 device; the busiest year was 2013 with 1.

100% of its events are Class I; the most common class is Class I (3). 0 events are listed as ongoing; the recalling firm's address is in CA.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

Initiated	Product (first record)	Type	Class	Records	Status
17 May 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.	Device	Class I	12	Terminated
3 Apr 2015	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.	Device	Class I	1	Terminated
5 Sep 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…	Device	Class I	1	Terminated

By type and class

Device3

Class I3

Class I: 100% of this firm's events; 18% of all events on the register.

Events by year

Enforcement events for Carefusion 211 Inc dba Carefusion by year initiated.

Questions and answers

How many FDA recalls has Carefusion 211 Inc dba Carefusion had?

3 enforcement events (14 product records) on this register, 2013–2016: 3 device.

Are any Carefusion 211 Inc dba Carefusion recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are Carefusion 211 Inc dba Carefusion recalls?

3 Class I. 100% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.