FOR IMMEDIATE RELEASE — May 27, 2015 — San Diego, CA — CareFusion, a BD company (NYSE:BDX), provided an update on a global voluntary recall that was initiated on April 21, 2015 to address an issue with certain units of AVEA® ventilators.
The recall has been designated as a Class I recall by the U.S. Food and Drug Administration (FDA), which means the Agency believes that there is a reasonable probability that use of the recalled product will cause serious adverse health consequences or death. To date, no report of patient injury has been received related to this issue.
The AVEA ventilator is only used in hospitals and other health care facilities and is intended for continuous breathing support for neonatal through adult patients. The recall is in response to a potential malfunction of an AVEA ventilator specific 5 psi pressure transducer. The affected AVEA ventilators may develop a failure mode over a period of time, where, by design, the ventilator activates false Extended High Ppeak or Circuit Occlusion audio and visual alarms, opens the safety valve and stops ventilating. If this occurs, alternate ventilation support will be required to reduce the potential of hypoxemia or hypercapnia.
The global recall involves AVEA ventilators manufactured, serviced and distributed from July 1, 2011 to March 15, 2015. CareFusion learned of this issue through customer reports identifying Extended High Ppeak or Circuit Occlusion alarms. A list of affected model and serial numbers is available at the CareFusion website. Refer to Figure 1 for the location of model and serial numbers.
CareFusion puts patient safety first and will continue to work diligently with customers and global regulatory authorities to resolve this issue in a timely manner. The company has notified customers of the recall with an urgent recall letter. The CareFusion Recall Support Center is contacting global customers via telephone to coordinate on-site AVEA ventilator correction in a timely, effective manner.
The FDA and other regulatory authorities have been notified.
Instructions to Customers
CareFusion does not require the return of affected AVEA ventilators. Continue reading