Another Class I recall for Hospira's GemStar infusion system
FDA regulators again put their highest-risk label on a recall of Hospira's GemStar portable infusion system, this time over concerns about its pressure sensors.
FDA regulators issued their highest-risk Class I status on a recall of Hospira's (NYSE:HSP) GemStar portable infusion systems, warning that issues with the devices' pressure sensors may result in significant patient harm or death.
The affected GemStar systems may experience stopped or delayed therapy, display a litany of warnings, fail to detect occlusions or exhibit other unusual behavior due to issues with the pressure sensors, according to the FDA memo. The recall includes 6 models that were either manufactured or had their pressure sensors replaced after Jan. 1, 2009.