Three situations described in the recall, which was announced on June 30, were designated as FDA Class I recalls (the most serious kind), meaning that there is reasonable probability that use of the product will cause serious adverse health incidents or death, according to a news release.
One situation was tabbed as a Class II recall, meaning use of the product may cause temporary or medically reversible adverse health consequences where the probability of serious incidents is remote.
The FDA’s classification has no impact on the original guidance issued by BD when it initially announced the recall, as the company notified customers of four potential hardware situations that may result in the infusion pump not operating as expected:
- 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)
BD’s Alaris system is an infusion pump and vital signs monitoring system designed to deliver fluids, medications, blood and blood products in controlled amounts. The latest recall is the most recent one related to the device, which, back in February, was recalled for multiple issues.
Then, the company cited multiple system errors, software errors, and use-related errors. All lots of five different models of the Alaris system were included in the recall that Becton Dickinson initiated on Feb. 4. In total, the company recalled 774,000 devices in the U.S. According to a news release at the time, there were 55 reported injuries and one death related to the issues.