Massachusetts-based medical device maker Covidien (NYSE:COV) announced a voluntary recall of certain Power Pac batteries distributed with its Newport HT70 and HT70 Plus ventilators, according to an FDA notice.
Covidien launched the recall in response to reports that some batteries were resorting to back-up power sooner than expected while operating on the Power Pac battery. In some instances the ventilator may erroneously indicate that the Power Pac is fully charged, and in other instances the ventilator may resort to a backup battery as soon as its unplugged from AC power, the company said.
"In both situations, the ventilator’s alarm sounds and the ventilator will continue to function on the internal backup battery for at least 30 minutes," according to the notice. "There is a reasonable likelihood of serious adverse health consequences if these issues occur when the user is away from AC power (including during transport) and an alternate source of power cannot be made available before the charge on the internal battery is depleted."
Covidien is recalling Power Pac batteries with serial numbers between 2096134110001 and 2292048120050, which the company says were distributed in the U.S. The company also alerted its customers with a warning letter issued April 4, providing instructions for obtaining a replacement battery.