FDA Expands Sigma Pump Recall

The U.S. Food and Drug Administration (FDA) announced that medical device maker Sigma is expanding its prior Class I recall of the Sigma Spectrum Infusion Pump Model 35700.

Class I recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of these products will cause serious adverse health consequences or death.

Based on additional analyses since the initial July 2011 recall, Sigma has expanded its recall to include additional devices manufactured from January 18, 2005, through November 1, 2010, with certain exceptions for pumps already remediated following the initial recall, according to the FDA.

The pump is used to help deliver fluids, solutions, drugs, blood thinning products, and nutritionals to patients. The recall was issued because these units may fail suddenly causing inaccurate flow conditions during use. The recalled pump does not issue an alarm when this happens, which could lead to serious injury or death in patients.

If you or a loved one has been harmed by an unsafe medical device, contact Sokolove Law for a free legal consultation and to find out if a product liability lawyer may be able to help you. For legal help, call (800) 581-6358.