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www.fdanews.com/articles/172685-carefusion-recalls-over-7000-units-of-alaris-syringe-pump

CareFusion Recalls Over 7,000 Units of Alaris Syringe Pump

August 18, 2015

CareFusion is recalling 7,481 units of its Alaris Syringe Pump after the FDA issued a Class 1 Recall notice. The FDA says in the notice that “the channel error will cause an audible and visual alarm on the Alaris PC unit and a channel error on the Alaris Syringe.”

The recall covers model 8110, which was manufactured between March 2014 and September 2014 and has been distributed in Australia, New Zealand, South Africa, Canada, the Middle East, Malaysia and Taiwan.

The recall is CareFusion’s ninth Class 1 recall of an Alaris device since 2010.

CareFusion will take up corrective action by replacing the syringe drive train assembly on the affected units and adjust, if required, and by contacting all affected customers within 60 days to initiate the scheduling process for the remediation, according to the notice. — Michael Cipriano