BD Alaris Pump Module Model, 8100 with Guardrails, Suite… recallZ-2179-2025 · CareFusion 303, Inc. · initiated Jul 8, 2025
Open, Classified
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from CareFusion 303, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
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.
FDA root cause category: Under Investigation by firm
What the company is doing
On December 12, 2025, CareFusion 303, Inc. (BD) issued a updated "Urgent Medical device Recall Notice via E-Mail and physical mail. The updated notice includes important information on infusion sets as well as labeling updates. Previous notifications were sent on July 8,2025, July 17, 2025, September 11, 2025 and September 12, 2025. CareFusion ask consignees to take the following actions: 1. Review your inventory for the catalog numbers included in the updated letter. Remove and discard any remaining inventory per your facility guidelines. 2.To receive credit or replacement product, please return the completed customer response form attached to this notice. 3.Please contact your BD Clinical Consultants and Account Executives for alternative sets information. 4. Review the updated sets performance data included in the letter. 5. Circulate this notice within your facility network to ensure that all concerned personnel are made aware of this issue. 6. Distributors should provide a copy of this notice to all customers who may have purchased an Alaris Pump Module. If you require further assistance, please contact: BD Technical Support at Phone: 888-812-3229; Phone hours: 6:00am to 5:00pm PT Monday Friday and Email: [email protected].
Recall details
- Recall number
- Z-2179-2025
- Status
- Open, Classified
- Initiated by the company
- Jul 8, 2025
- Posted by the FDA
- Aug 6, 2025
- Recalling firm
- CareFusion 303, Inc.
- Quantity
- 33,162,680 units total
- Product code
- FRN
- FDA submissions
- K211218
- Distribution
- US Nationwide Distribution to states of: AK AL AR AS AZ CA CO CT DC DE FL GA GU HI IA ID IL IN KS KY LA MA MD ME MI MN MO MP MS MT NC ND NE NH NJ NM NV NY OH OK OR PA PR RI SC SD TN TX UT VA VT WA WI WV WY; and OUS (foreign) to countries of: Japan, Italy, Germany, Turkey
Product description
BD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
Code information (models, lots, serial numbers)
BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046
Devices named in this recall
5 devices in the FDA device registry whose identifier appears in the recall's code information.
- Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls2 deaths650,218 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion4 recalls78 deaths344,514 reports
- BD® Alaris™ Pump Module, Model 8100Carefusion 303, Inc. · Pump, infusion5 recalls30 deaths51,256 reports
- Alaris 8100Carefusion 303, Inc. · Pump, infusion3 recalls1 death6,859 reports
- BD Alaris 8100Carefusion 303, Inc. · Pump, infusion2 recalls0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97067).
- Z-2180-2025 · Open, ClassifiedBD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartSite Y-sites LVP 60D DEHP FREE 3SS CV; REF: 2452-0007, BD Alaris Pump Infusion S…
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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