FDA Labels Becton Dickinson’s Infusion Pump Recall as Class I
The FDA has classified Becton Dickinson’s recall of its BD Alaris infusion pump and vital signs monitoring system as Class I, indicating that there is a reasonable probability that use of the product will cause serious adverse health consequences or death.
The company initiated a recall in August of its BD Alaris PC Unit 8015 and five keypad replacement kits because one or more keys may become unresponsive or stuck. The system is used in hospitals and other healthcare facilities to deliver controlled amounts of medications, fluids, blood and blood products into a patient’s body.
Use of the defective devices could lead to patient injury or death, the agency warned, noting that 1,186 issues and a single injury have been reported so far. The recalled devices should be removed from service, the FDA said.