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GE Healthcare Announces Class I Recall of Infant Resuscitation Kits



2/4/2013 8:27:00 AM

Healthcare giant GE recalls a resuscitation upgrade kit installed in certain infant warmers over concerns that mix-ups in labeling could lead to significant harm. The FDA gave Class I status to GE Healthcare's (NYSE:GE) recall of upgrade kits for some infant warmers over concerns that mislabeling in the kits may result in neonatal patients getting the wrong oxygen concentrations. The recall affects field upgrade kits for the company's resuscitation systems with blender, which are installed in GE Giraffe and Panda infant warmers, the company reported. "The oxygen and air wall inlet fittings and/or labels on the back panel may have been reversed during assembly," according to a statement. "As a result, this could potentially reverse the air/oxygen mixer concentrations; for example, a setting of 100% oxygen could have an output of 21% oxygen, and vice versa. The settings of the blender knob would no longer be accurate."

Read at MassDevice


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