The FDA has widened an existing Class 1 recall of a popular infusion pump to include a greater number of units than it previously deemed problematic. The affected product line, Sigma’s Spectrum model 35700, may fail to function properly in a number of ways while also failing to issue an alarm.
Depending on the substance or agent being administered by the device, serious injury or death could result, said the FDA in its updated recall notice.
The notice stated that Sigma’s customers have been instructed to check inventories against the affected serial numbers, which the notice provides, and to return all affected units to the company for precautionary service or replacement.
The notice does not say how the problems were discovered.
The FDA issued the expanded recall June 15—the same day Sigma’s Spectrum line was recognized, for the second year in a row, as the favorite in its class among end users and related provider personnel.
Sigma is headquartered in Medina, N.Y.