CareFusion 303, Inc. recalls BD Alaris Pump Infusion Sets REF: 10013186
Reason for recall
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.
Affected product
Check your device
Enter a lot, serial, REF, or UDI number from your device's label to check it against this recall's listed codes.
Affected products & lots
- 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
- 2452-0007, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 10D 3SS 2CVREFUDI 07613203021135REF 10010453/
- 2204-0007, BD Alaris Pump Infusion SetAS LVP 20DREFUDI 07613203021135REF 10010453/
- 24001-0007, BD Alaris Pump Infusion Set, Back Check Valve, SmartSite Y-siteAS LVP 20D SS CVREFUDI 07613203021135REF 10010453/
- 10015012, BD Alaris Pump Infusion Burette Set, 0.2 Micron Filter, Smallbore Tubing, SmartSite Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2MREFUDI 07613203021135REF 10010453/
- 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CVREFUDI 07613203021135REF 10010453/
- 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CVREFUDI 07613203021135REF 10010453/
- 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2MREFUDI 07613203021135REF 10010453/
- 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CVREFUDI 07613203021135REF 10010453/
- 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CVREFUDI 07613203021135REF 10010453/
- 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15MREFUDI 07613203021135REF 10010453/
- 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CVREFUDI 07613203021135REF 10010453/
- 11532269, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, PE Lined Tubing, 2 SmartSite Y-sitesAS LVP 20D PE-LINED 2SS 0.2M CVREFUDI 07613203021135REF 10010453/
- 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2MREFUDI 07613203021135REF 10010453/
- 2465-0007, BD Alaris Pump Infusion Set, SmartSite Bag Access Non-Vented, 0.2 Micron Filter, Low Sorbing Tubing (PE Lined), SmartSite Y-siteAS LVP SS BAG 20D PE-Lined SS 0.2MREFUDI 07613203021135REF 10010453/
- 10010453, ASBD Alaris Pump Infusion Set, 1.2 Micron Filter, PE Lined Tubing, SmartSite Y-site LVP 20D PE-LINED TUBING SS 1.2M REF: 11419365, BD Alaris" Pump Infusion Set, Back Check Valve, Manifold, 3-Way Stopcock, 5 SmartSite" Y-sites REF: 10813621, BD Alaris" Pump Infusion Set, Back Check Valve, 3 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 2423-0007, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 4 SmartSite" Y-sites REF: 10015896, BD Alaris" Pump Infusion Set, Back Check Valve, 2 Ganged 4-Way Stopcocks, 3 SmartSite" Y-sites REF: 24010-0007T, BD Alaris" Pump Infusion Set, Bonded Texium", Closed Male Luer with Priming Cap, Back Check Valve, 3 SmartSite" Y-sites REF: 10010483, BD Alaris" Pump Infusion Set, Vented Syringe Adapter, Smallbore Tubing REF: 2403-0007, BD Alaris" Pump Infusion Set, Half Set, SmartSite" Y-site REF: 24301-0007T, BD Alaris" Pump Infusion Set, SmartSite" Bag Access Non-Vented, 0.2 Micron Filter, PE Lined Tubing, Bonded Texium" Closed Male Luer with Priming Cap, SmartSite" Y-siteREFUDI 07613203021135REF 10010453/
What the firm 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: DL-US-INF-TechSupport@bd.com.
DistributionShow detailsHide
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
A reasonable probability that use of the product will cause serious adverse health consequences or death.
Sources & references
- FDA enforcement recordOfficial FDA database entry for Z-2180-2025
- FDA 510(k) clearance · K022209The device's official FDA premarket clearance record
- FDA device classification · FRNOfficial FDA classification for this device type
- CFR regulation · 21 CFR 880.5725The federal regulation governing this device
- FDA recall announcementSearch FDA.gov for the official press announcement
- Find CareFusion 303, Inc.Search for the manufacturer's official notice
- News coverageRecent reporting on this recall and manufacturer
- openFDA data recordThe raw JSON record this page is built from
Source: U.S. FDA openFDA device enforcement reports. This summary is informational and may lag or differ from the official record. Always verify against the FDA before acting.
Taylor Coteus is RecallWatch's Legal News Analyst, covering FDA medical-device enforcement and patient-safety litigation. He reviews every recall against the FDA's official openFDA record before it is published and is responsible for corrections and editorial accuracy.
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