GE recalls infant resuscitation circuits as FDA warns of fatal risk
GE Healthcare ($GE) is in the process of recalling T-piece circuits used in two infant resuscitation devices, and the FDA says the malfunctioning components could result in injury or death.
The circuits are used with the Panda and Giraffe devices, GE said, and they can occasionally fail to produce sufficient inspiratory pressure, leaving patients at risk. GE first notified customers back in June and has since corrected or destroyed 84% of the affected units.
So far, there have been no reported injuries in patients using the circuit, GE says, and the FDA is asking patients and physicians to report any adverse events through its online MedWatch program.
The affected lots were manufactured between September 2009 and May 2012, and the recall affects only the circuits marked with a red inspection stamp, according to GE.
- here's the release