Recall Z-2273-2013— Carefusion 211 Inc dba Carefusion

Name: FDA recall Z-2273-2013
Creator: U.S. Food and Drug Administration
Published: 2013-09-05

Class I · Terminated

Class I FDA medical device recall by Carefusion 211 Inc dba Carefusion, initiated 2013-09-05, terminated 2015-06-04. It names 3 FDA 510(k) clearances: K103211, K073069, K013642. Product: 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 percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.. Reason: 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..

Recalling firm: Carefusion 211 Inc dba Carefusion
Classification: Class I
Status: Terminated
Initiated: 2013-09-05
Terminated: 2015-06-04
Firm location: Yorba Linda, CA, United States

510(k) clearances named in this recall

3 on FDA's record

K103211 — AVEA VENTILATORCare Fusion·cleared 2011-05-12
K073069 — MODIFICATION TO AVEA VENTILATORViasys Respiratory Care, Inc.·cleared 2008-01-25
K013642 — AVEABird Products Corp.·cleared 2002-05-22

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

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 percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.

Reason for recall

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.

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