—#214407

Product

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

FDA product code: FRN — Pump, Infusion
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K211218
Affected lot / code info: BD Alaris" Pump Module Model 8100- All Serial Numbers/ UDI(s): 10885403222054, 10885403517723, 10885403810015, 10885403810039, 10885403810046

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.

Root cause (FDA determination)

Under Investigation by firm

Action the firm took

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: DL-US-INF-TechSupport@bd.com.

Recalling firm

Firm: CareFusion 303, Inc.
Address: 10020 Pacific Mesa Blvd, San Diego, California 92121-4386

Distribution

Distribution pattern: 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

Timeline

Recall initiated: 2025-07-08
Posted by FDA: 2025-08-06
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #214407. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.