Reported Nov 26, 2025 · Ongoing

BD Alaris infusion Pump Module 8100, REF: 8100; KIT, BEZEL ASSY 8100BD, REF: 49000437; KIT ASSY ONE PIECE BEZEL 8100,…

CareFusion 303, Inc.

High riskUsing this product could cause serious injury, illness or death — stop using it now.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: CareFusion 303, Inc. · 10020 Pacific Mesa Blvd · San Diego, CA · 92121-4386

Is this the product you have?

5 of 5 products

Products covered by this recall
Model / numberProduct as published
8100BD Alaris infusion Pump Module 8100
49000437KIT, BEZEL ASSY 8100BD
BD-163124KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, , Revision: 00
P00000864Cleaning and Disinfecting Procedure
Cleaning and Disinfecting Quick Reference Guide
Lot codes and dates

3 of 3 products · 9 lot codes

Recalled lot codes, grouped by product number
REFUDI-DI
8100
  • 10885403810015
  • 10885403810046
  • 10885403810039
  • 10885403222054
  • 10885403517723
  • 10885403213212
  • 10885403211423
49000437
  • 10885403471018
49000270
  • 10885403247743
Amount recalled
2,574,396

Where it was sold

Why it was recalled

Stop using this product now

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.

Using this product could cause serious injury, illness or death — stop using it now.

Want the full recall guide?

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

Get alerted about new CareFusion 303, Inc. recalls

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Data as of Sep 19, 6:19 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.