FDA Recalls Sigma Infusion Pumps

June 18, 2012
June 18, 2012

Earlier this week, the US Food and Drug Administration (FDA) announced a Class I recall for Sigma Spectrum Infusion Pump Model 35700 with serial numbers 700000 to 794213, manufactured on January 18, 2005 to November 1, 2010. Sigma International General Medical Apparatus, the manufacturer of the infusion pump device issued the recall, the agency stated.

The Spectrum Infusion Pump 35700 infusion pump is designed to deliver nutritional fluids, drugs and blood products to neonatal, pediatric and adult patients. Following the initial recall on November 10, 2010, the FDA stressed that the identified units do not emit alarm signals during inaccurate flow conditions and unsafe operation such as back flow, free flow and over-infusion.

Prior recall expansion on the units was issued on July 2011. The FDA exempted the pump units manufactured after November 1, 2010 and those serviced after September 21, 2010. Units covered in the Class I recall should immediately be returned to Sigma. The FDA Class I Recall is issued for products that could “cause serious adverse health consequences or death”.

To provide high-quality patient care and decreased medication error, clinicians and healthcare facilities are advised to use only well-serviced infusion pump systems. AIV offers parts and services for most leading infusion pumps in the market. Browse through AIV’s replacement parts and repair services at http://www.aiv-inc.com/iv-infusion-pump-replacement-parts.html.

About the Author

Laura Collier

Laura Collier

Laura Collier has a Bachelor’s Degree in Communications and a Master’s Degree in Business Administration from the University of North Florida. She is the Marketing Manager at AIV, Inc.

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