Expanded Class 1 Recall:SIGMA Spectrum Infusion Pump Model 35700

Based on additional analyses since the initial recall, SIGMA expanded their recall to include additional affected units manufactured from January 18, 2005 through November 1, 2010, with the exception as noted above. These units may fail suddenly causing inaccurate flow conditions during use, ranging from back flow to over-infusion, including free flow. The pump does not issue an alarm when this occurs. These conditions could result in serious injury or death.