FDAJuly 8, 2025device

BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post-occlusion bolos volume.

What to do

FDA enforcement status: Ongoing

Brands named

carefusion 303carefusion

UPCs

1088540322205410885403517723108854038100151088540381003910885403810046

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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