Federal regulators have posted two separate Class I actions involving the same family of hospital infusion pumps, the machines that push chemotherapy, antibiotics, IV fluids, blood products, and pain medication into patients at a controlled rate.
Neither action removes the pumps from hospitals. Both are corrections, meaning the devices stay in service and must be fixed or handled differently. The FDA applied its most serious recall classification to each, a designation reserved for problems that could cause serious injury or death if the device continues to be used without correction.