The FDA expanded a recall for the SIGMA Spectrum Infusion Pump Model 35700, since additional pumps have proven defective. These pumps are used for infusion of fluids, drugs and other solutions. The defect causes the pump to “fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow.” Further, “[t]he pump does not issue an alarm when this occurs.” According to the FDA, “[t]hese conditions could result in serious injury or death.”
