The U.S. Food and Drug Administration (FDA) has expanded the Class I recall of the Sigma Spectrum Infusion Pump Model 35700 again. The pump, manufactured by Sigma LLC, was recalled first in November 2010. The recall affected pumps with serial numbers between 706497 and 724065. The recall was expanded in July of last year, and again now.

The recall was issued because of the risk for the pumps to fail, causing sudden inaccurate flow conditions ranging from back flow to over-infusion, including free flow. Because the pump does not alert the clinician when it fails, it could cause injury or death to the patient.

The FDA has now expanded the recall to include pumps with serial numbers between 700000 and 794213. Any pump manufactured after November 1, 2010, are exempt, as well as units remediated by the company after September 2010.

The pump is used to deliver fluid through parenteral, enteral, intravenous, intra-arterial, subcutaneous, epidural, and irrigation routes.

Sigma manufactures infusion pumps and is based in Medina, N.Y. Medical device company Baxter owns 40 percent of the company.

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