The medical devicemaker’s Infusomat Space Volumetric Infusion Pump System might have faulty occlusion alarms and suddenly stop delivering medications, “such as high-risk medications like vasopressors,” the FDA said Nov. 17.
The agency labeled the concern as a Class I recall, the most serious type. B. Braun Medical is not recalling the 10,655 devices; rather, the company is recommending healthcare workers use the pumps for low-risk drugs, or have a backup pump available for high-risk medications