BD updated a Class I recall announced on June 30, 2020 for the BD Alaris System due to hardware issues that may cause the infusion pump to not operate as expected.
Three of the situations described in the company recall, which BD announced on June 30, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means 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 June recall announcement to customers.
There are 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.
The four situations include:
· Damaged Inter-Unit Interface (IUI) Connectors (Situation 1 – Class I)
· Broken elements on Alaris Pump Module platen (Situation 2 – Class I)
· Improperly secured PC unit Battery (Situation 3 – Class I)
· Dim LED Segment(s) on the Alaris modules (Situation 4 – Class II)
Situation 3 affects the batteries of the PC Units, which may cause power loss to any attached module. Some affected devices may be branded under the CareFusion name.
