FDA Issues Alert on Becton Dickinson Infusion Pump Recall
The FDA has issued an update on a Class I recall of the BD Alaris infusion pump and vital signs monitor by Becton Dickinson (BD) subsidiary CareFusion 303.
CareFusion recalled nearly 145,500 model 8100 devices on March 3, citing a risk of the keypad lifting up and becoming unresponsive or stuck, which could cause interruptions in infusions for patients. The agency said 79 complaints were filed, but there were no reports of serious adverse events or death.
The problem was traced to a supplier manufacturing process that affected pump modules. The company said corrective actions have been implemented.