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
| Model / number | Product as published |
|---|---|
8100 | BD Alaris infusion Pump Module 8100 |
49000437 | KIT, BEZEL ASSY 8100BD |
BD-163124 | KIT ASSY ONE PIECE BEZEL 8100, REF: 49000270. Used with the following new and updated documents: BD Alaris Infusion System Inspection Safety Reminder, , Revision: 00 |
P00000864 | Cleaning 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 REF UDI-DI 810010885403810015108854038100461088540381003910885403222054108854035177231088540321321210885403211423
4900043710885403471018
4900027010885403247743
- 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.
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