SAN DIEGO, Oct. 15 /PRNewswire/ -- CareFusion (NYSE: CFN), a leading, global medical device company, issued the following update regarding its previously disclosed recall of approximately 17,000 Alaris® PC units model 8015 manufactured or serviced between December 2008 and September 2009. The FDA has classified this action as a Class I recall. A Class I recall is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
On August 24, 2010, the company sent an urgent Medical Device Recall Notification to customers of its Alaris PC unit model 8015 stating that under certain wireless network conditions, affected units may experience an intermittent communication error, which freezes the PC unit screen. This error may result in a delay of therapy and inability to make programming changes to current infusions. If the communication error occurs during infusion, infusion continues on all channels, as originally programmed, but cannot be modified. When this error occurs, stopping the infusion to make any modification or programming changes causes the PC unit to shut down with a delay in therapy, which could lead to a serious injury or death.
In the notification letter, customers were provided clinical tip sheets and informed of warning tags for each of the affected units. Customers were also given instructions on how to temporarily or permanently disable the wireless mode of the PC unit setting to further mitigate the risk. This information is available at: http://www.carefusion.com/customer-support/alerts/alaris/medical-device-recall-alaris-8015.aspx
CareFusion is conducting a field corrective action to update the hardware on affected PC units.</