(Reuters) - Health regulators announced a recall of CareFusion’s Alaris pump module Model 8100, saying a potential keypad malfunction in the infusion pump could cause serious injury or death.
The U.S. Food and Drug Administration said the affected pump modules, used for delivering a variety of fluids, drugs and blood products to patients, were manufactured between October 2011 and February 2012.
According to the recall notice, CareFusion identified a potential problem whereby the overlay on the pump module’s keypad could detach, possibly allowing for fluid ingress into the assembly that could cause infusion to stop.
The FDA classified the action as a Class I recall on its website, meaning that the defective units could cause serious harm to a patient’s health.
Earlier this month, the FDA had announced a Class I recall of another CareFusion pump, the Alaris PC unit Model 8015, citing a malfunction in its power supply board.
Shares of CareFusion closed at $26.61 on the New York Stock Exchange on Wednesday.
(This story corrects headline of August 22 story to show that CareFusion, not the FDA, voluntarily initiated the recall. Also adds detail about the potential malfunction in paragraph three)
Reporting by Balaji Sridharan in Bangalore; Editing by Anthony Kurian