Recall Z-2179-2025— CareFusion 303, Inc.

Name: FDA recall Z-2179-2025
Creator: U.S. Food and Drug Administration
Published: 2025-07-08

Class I · Ongoing

Class I FDA medical device recall by CareFusion 303, Inc., initiated 2025-07-08. It names one FDA 510(k) clearance: K211218. Product: BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions. Reason: 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..

Recalling firm: CareFusion 303, Inc.
Classification: Class I
Status: Ongoing
Initiated: 2025-07-08
Firm location: San Diego, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K211218 — BD Alaris System with Guardrails Suite MX v12.1.2Carefusion 303, Inc.·cleared 2023-07-21

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

Reason for recall

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.

Data sourced from openFDA. This site is unofficial and independent of the FDA.