BD Alaris Pump Infusion Sets (CareFusion) – Flow Rate Issue (2025)
Hazard assessment based on recall description.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
BD 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 Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CV; REF: 2204-0007, BD Alaris Pump Infusion SetAS LVP 20D; REF: 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CV; REF: 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite P
Brand
CareFusion 303, Inc.
Lot Codes / Batch Numbers
REF: 10013186/ UDI: 07613203021173, REF: 2452-0007/ UDI: 10885403219870, REF: 2204-0007/ UDI: 10885403199363, REF: 24001-0007/ UDI: 10885403238666, REF: 10015012/ UDI: 10885403233951, REF: 2432-0007/ UDI: 10885403232329, REF: 2434-0007/ UDI: 07613203019682, REF: 2202-0007/ UDI: 10885403274039, REF: 11426965/ UDI: 10885403232558, REF: 10561554/ UDI: 10885403232565, REF: 10863358/ UDI: 10885403232466, REF: 11171447/ UDI: 07613203021234, REF: 11532269/ UDI: 10885403232343, REF: 10010454/ UDI: 07613203015806, REF: 2465-0007/ UDI: 10885403221941
Products Sold
REF: 10013186/ UDI: 07613203021173; REF: 2452-0007/ UDI: 10885403219870; REF: 2204-0007/ UDI: 10885403199363; REF: 24001-0007/ UDI: 10885403238666; REF: 10015012/ UDI: 10885403233951; REF: 2432-0007/ UDI: 10885403232329; REF: 2434-0007/ UDI: 07613203019682; REF: 2202-0007/ UDI: 10885403274039; REF: 11426965/ UDI: 10885403232558; REF: 10561554/ UDI: 10885403232565; REF: 10863358/ UDI: 10885403232466; REF: 11171447/ UDI: 07613203021234; REF: 11532269/ UDI: 10885403232343; REF: 10010454/ UDI: 07613203015806; REF: 2465-0007/ UDI: 10885403221941; REF: 10010453/ UDI: 07613203021135 REF: 11419365/ UDI: 10885403234736 REF: 10813621/UDI: 10885403234514 REF: 2423-0007/UDI: 07613203020985 REF: 10015896/UDI: 10885403234064 REF: 24010-0007T/UDI: 10885403271021 REF: 10010483/UDI: 10885403232602 REF: 2403-0007/UDI: 10885403232473 REF: 24301-0007T/UDI: 10885403223198
CareFusion 303, Inc. is recalling BD Alaris Pump Infusion Sets REF: 10013186, BD Alaris Pump Infusion Set, Back Check Valve, 3 SmartS due to Infusion pump module used with compatible pump infusion sets may perform outside the established performance ranges for flow rate and bolus accuracy. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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.
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026