CareFusion 303, Inc. recalls BD Alaris infusion Pump Module 8100

Recalling company

CareFusion 303, Inc.

Product

BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, Part: BD-163124, Revision: 00; Cleaning and Disinfecting Procedure, Part: P00000864; Cleaning and Disinfecting Quick Reference Guide

Reason

If infusion pump is dropped or severely jarred this may damage the pump module bezel assembly, which can cause under-infusion, over-infusion, unregulated flow, or pump module failure to calibrate; so dropped/jarred pumps should be removed from use, tested, and inspected by qualified service personnel prior to reuse; tip sheet, cleaning and disinfecting procedure and reference guide updated.

Classification

Class I – a reasonable probability that use will cause serious adverse health consequences or death

Recall date

Oct 17, 2025

Reported

Nov 26, 2025

Distribution

Worldwide distribution. US nationwide including Puerto Rico, Guam, American Samoa, Northern Mariana Islands; and countries of SG, BH, AE, JP, CA, IT, QA, PH, DE, TW, PK, KR, BW, SA, MY, IL, NZ, AU, IN, GB, CN, NL, FR, ZA, BE, MX, CH, GI, KW, and TR.

Status

Ongoing

Quantity

2,574,396

Lot / codes

All Alaris Pump Modules distributed after June 19, 2004. REF/UDI-DI: 8100/10885403810015, 10885403810046, 10885403810039, 10885403222054, 10885403517723, 10885403213212, 10885403211423; 49000437/10885403471018; 49000270/10885403247743

Company location

San Diego, CA

Recall type

Voluntary: Firm initiated

Recall number

Z-0430-2026

Agency

U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number Z-0430-2026 in the FDA Enforcement Report. Also see FDA recall press releases.