BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on previously announced voluntary recalls of the BD Alaris™ System.
Three of the recalls, which BD announced on Aug. 4, 2020 External Link Disclaimer, External Link Disclaimer have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
This FDA classification does not change the guidance BD provided in the company’s Aug. 4 External Link Disclaimer
BD initiated the voluntary recalls to notify customers of the potential for four hardware situations that may result in the infusion pump not operating as expected. BD has provided instructions to correct and/or mitigate the situations.
Recall
