Recall Z-1609-2015— Carefusion 211 Inc dba Carefusion

Name: FDA recall Z-1609-2015
Creator: U.S. Food and Drug Administration
Published: 2015-04-03

Class I · Terminated

Class I FDA medical device recall by Carefusion 211 Inc dba Carefusion, initiated 2015-04-03, terminated 2018-07-23. It names one FDA 510(k) clearance: K103211. Product: 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.. Reason: A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator..

Recalling firm: Carefusion 211 Inc dba Carefusion
Classification: Class I
Status: Terminated
Initiated: 2015-04-03
Terminated: 2018-07-23
Firm location: Yorba Linda, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K103211 — AVEA VENTILATORCare Fusion·cleared 2011-05-12

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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.

Reason for recall

A pressure transducer failure can develop, activating a false Extended High Ppeak or Circuit Occlusion Alarm. The Safety Valve will open to ambient air and the unit will stop ventilating, allowing spontaneous breathing patients to breathe. The malfunction may delay initiation or cease ventilation. Nonbreathing patients will need manual ventilation or to be connected to another ventilator.

Data sourced from openFDA. This site is unofficial and independent of the FDA.