Becton Dickinson Gives Update on Infusion Pump Recall
Becton Dickinson (BD) said that the FDA has classified three of the four hardware problems that led to a June 30 recall of the BD Alaris large-volume infusion pump system as Class I, meaning there is a reasonable probability they could cause serious adverse health events or death.
The three Class I issues involved damaged interface connectors, broken parts of the pump module and a battery problem that could cause power loss.
One problem described in the recall, in which parts of the LED display appear dim, was classified as Class II, meaning use of the product may cause temporary or medically reversible adverse health events.
Becton Dickinson said the FDA’s classification does not change the guidance the company provided to customers in the original recall announcement.