BD (Becton, Dickinson and Company), provided an update on a previously announced voluntary recall of the BD Alaris System, states a press release from the company.
Three of the situations described in this 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 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 June recall announcement to customers. BD initiated the voluntary recall 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. 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)
Customers should review and follow the instructions in the recall letter at www.bd.com/en-us/support/recall-notifications/recall-notification-for-alaris-system-infusion-pump-hardware.
Affected Products:
· Alaris System PC Unit Model 8000
· Alaris System PC Unit Model 8015
· Alaris Pump Module Model 8100
· Alaris Syringe Module Model 8110
· Alaris PCA Module Model 8120
· Alaris EtCO2 Module Model 8300
· Alaris SpO2 Module Model 8210 and Model 8220
· Alaris Auto ID Module Model 8600
Since Situation 3 affects the batteries of the PC Units, it may cause power loss to any attached module. Some affected devices may be branded under the CareFusion name.
