BD Issues Class I Recall of Alaris System Infusion Pumps

March 10, 2020
BD Issues Class I Recall of Alaris System Infusion Pumps

On February 4, 2020, BD announced a recall of all lots of affected models of its Alaris System pump modules because of multiple system errors, software errors, and use-related errors. On March 6, 2020, the U.S. Food and Drug Administration identified it as a class I recall, its most serious level of recalls, because of the possibility of serious injuries or death.

The 774,000 affected units were distributed from July 2004–January 23, 2020, under the following models:

Modules with software version 9.33 or earlier may experience:

For modules with software version 12.1.0, the following issues apply:

The errors can lead to delay in infusion, interruption of infusion, slower-than-expected delivery of medication (underinfusion), and faster-than-expected delivery of medication (overinfusion). Serious adverse health events have occurred with each of the errors. Fifty-five injuries and one death were reported.

BD has contacted its customers about the affected models. Consumers with questions may reach BD at 888-562-6018, Monday–Friday from 7 am–4 pm Pacific Time, or at supportcenter@bd.com.


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