SIGMA Spectrum Infusion Pumps, used to deliver fluids and other products into the body, are being recalled by the Food and Drug Administration (FDA) because the pumps may fail and lead to serious injury or death in patients using them. The recall is listed as a Class 1, the most serious type of recall, and  involves situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death. 

The recall affects the SIGMA Infusion Pump Model 35700 with serial numbers ranging from 706497 to 724065. The pumps were manufactured from October 2006 to March 2008 and are intended for the delivery of fluids, solutions, drugs, agents, nutritionals, electrolytes, blood and blood products via parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural or irrigation routes of administration.

The recall was initiated after it was discovered the units could 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.

The company has sent a recall notice to customers and instructed them to check their inventory to verify whether their serial numbers fall within the range of pumps being recalled. The company is servicing or replacing all affected pumps and has issued instructions for users.

Any side effects or adverse events associated with this or any other medical product should be reported to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/Medwatch.