Symbios Medical Products recalled certain lots of its GOPump Elastomeric Infusion PumpKit systems over concerns that a component that moderates the flow of medicine from the pump may fail and cause an overdose.
The FDA placed Class I status on the recall, a category reserved for issues which "may cause serious adverse health consequences, including death," according to an agency notice.
The Symbios pumps are self-contained infusion systems that provide prescribed medications at specified rates for help patients manage pain.
"The flow restrictor bead may become displaced from its fitting which may permit solutions to flow at a higher rate than intended," the FDA noted. "This product may cause serious adverse health consequences, including death."
The effected kits were distributed between September 2012 and last month, according to the warning.