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.</
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