The Recall Desk
Severity pendingFDA (Devices)·Z-2179-2025·Announced 2025-08-13

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

Pending LLM rewrite. Source: FDA_DEVICE Z-2179-2025.

Severity not yet assessed

We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.

Plain-English summary

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.

The recalled product

Product
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Manufacturer
CareFusion 303, Inc.

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (5)

  • BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054
  • 10885403517723
  • 10885403810015
  • 10885403810039
  • 10885403810046

Distribution

Distributed nationwide across the United States.