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SAN DIEGO, CA, May 27, 2015 /PRNewswire/ - 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.
In the interim, if an AVEA ventilator exhibits a sustained Extended High Ppeak or Circuit Occlusion alarm followed by the opening of the safety valve that cannot be cleared by powering the ventilator off and back on again, immediately remove the ventilator from service, provide alternate ventilation and contact CareFusion Technical Support at the contact information listed below to report the issue.
Customer inquiries related to this action should be addressed to the CareFusion Recall Support Center at 1.888.562.6018Call: 1.888.562.6018 or email SupportCenter@carefusion.com between the hours of 6:30 a.m. to 5:00 p.m. PDT.
For technical support or to report a problem, please contact CareFusion Technical Support at 1.800.231.2466Call: 1.800.231.2466 or email Support.Vent.US@carefusion.com.
Adverse reactions or quality problems experienced with the use of this product should be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax:
Countries with AVEA ventilators affected by the global recall:
|BA||Bosnia and Heherzegowina|
|CN||China (People's Rep)|
|HK||Hong Kong, China|
|MD||Moldova (republic of)|
|AE||United Arab Emirates|
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