Carefusion 211 Inc dba Carefusion: Medical Device Recall in 2016 - (Recall #: Z-1891-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

Product Description:

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.

Product Classification:

Class I

Date Initiated: May 17, 2016

Date Posted: June 22, 2016

Recall Number: Z-1891-2016

Event ID: 74111

Reason for Recall:

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).

Status: Terminated

Product Quantity: 922 units total (501 units in US)

Code Information:

Distribution Pattern:

Worldwide Distribution - US (Nationwide) and the countries of Australia, Hungary, Paraguay, Belgium, Indonesia, Philippines, Bolivia, Ireland, Poland, Bermuda, India, Saudi Arabia, Canada, Japan, Singapore, Chile, Jordon, South Africa, China, Kuwait, Taiwan, Ecuador, Malaysia, Thailand, Egypt, Mexico, Turkey, France, Netherlands, United Kingdom, Guatemala, and Nicaragua.

Voluntary or Mandated:

Voluntary: Firm initiated