BD Alaris Pump Infusion Sets recallZ-2180-2025 · 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-2180-2025
- 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
- K022209
- 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 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 Port (Burette), SmartSite Y-siteAS LVP BUR 20D PE-Lined SMBORE SS 0.2M; REF: 2432-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D 3SS 0.2M CV; REF: 2434-0007, BD Alaris Pump Infusion Set, 0.2 Micron Filter, Back Check Valve, SmartSite Y-siteAS LVP 20D SS 0.2M CV; REF: 2202-0007, BD Alaris Pump Infusion Set, 1.2 Micron FilterAS LVP 20D 1.2M; REF: 11426965, BD Alaris Pump Infusion Set, Back Check Valve, 5 SmartSite Y-sitesAS LVP 20D CV; REF: 10561554, BD Alaris Pump Infusion Set, 15 Micron Filter, Back Check Valve, 3 SmartSite Y-sitesAS LVP 20D DEHP FREE 3SS 15M CV; REF: 10863358, BD Alaris Pump Infusion Set, 15 Micron FilterAS LVP 20D DEHP FREE 15M; REF: 11171447, BD Alaris Pump Infusion Set, 2 Back Check Valves, 3 SmartSite Y-sitesAS LVP 20D 3SS 2CV; REF: 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 CV; REF: 10010454, BD Alaris Pump Infusion Set, 0.2 Micron Filter, PE Lined Tubing, SmartSite Y-siteAS LVP 20D PE-LINED TUBING SS 0.2M; REF: 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 0.2M; REF: 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-site
Code information (models, lots, serial numbers)
Show the full code information (1k characters)
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
Devices named in this recall
24 devices in the FDA device registry whose identifier appears in the recall's code information.
- Alaris, SmartSite 11532269BD Switzerland Sàrl · Set, administration, intravascular3 recalls332 reports
- Alaris, SmartSite 10010454BD Switzerland Sàrl · Set, administration, intravascular4 recalls212 reports
- Alaris 2202-0007BD Switzerland Sàrl · Set, administration, intravascular3 recalls248 reports
- Alaris, SmartSite 10010453BD Switzerland Sàrl · Set, administration, intravascular4 recalls165 reports
- Alaris, SmartSite 2432-0007BD Switzerland Sàrl · Set, administration, intravascular2 recalls256 reports
- Alaris, SmartSite, Texium 24301-0007TBD Switzerland Sàrl · Set, administration, intravascular4 recalls87 reports
- Alaris, SmartSite 11171447BD Switzerland Sàrl · Set, administration, intravascular4 recalls77 reports
- Alaris, SmartSite 10015012BD Switzerland Sàrl · Set, administration, intravascular3 recalls87 reports
- Alaris 2204-0007BD Switzerland Sàrl · Set, administration, intravascular3 recalls59 reports
- Alaris 10010483BD Switzerland Sàrl · Set, administration, intravascular3 recalls59 reports
- Alaris, SmartSite, Texium 24010-0007TBD Switzerland Sàrl · Set, administration, intravascular3 recalls54 reports
- Alaris, SmartSite 2465-0007BD Switzerland Sàrl · Set, administration, intravascular3 recalls45 reports
- Alaris, SmartSite 2423-0007BD Switzerland Sàrl · Set, administration, intravascular2 recalls48 reports
- Alaris, SmartSite 11426965BD Switzerland Sàrl · Set, administration, intravascular2 recalls31 reports
- Alaris, SmartSite 10813621BD Switzerland Sàrl · Set, administration, intravascular2 recalls11 reports
- Alaris, SmartSite 10561554BD Switzerland Sàrl · Set, administration, intravascular2 recalls4 reports
- Alaris, SmartSite 24001-0007BD Switzerland Sàrl · Set, administration, intravascular2 recalls2 reports
- Alaris, SmartSite 2403-0007BD Switzerland Sàrl · Set, administration, intravascular2 recalls1 report
- Alaris, SmartSite 11419365BD Switzerland Sàrl · Set, administration, intravascular2 recalls1 report
- Alaris, SmartSite 2434-0007BD Switzerland Sàrl · Set, administration, intravascular1 recall30 reports
- Alaris, SmartSite 2452-0007BD Switzerland Sàrl · Set, administration, intravascular1 recall24 reports
- Alaris, SmartSite 10015896BD Switzerland Sàrl · Set, administration, intravascular1 recall8 reports
- Alaris, SmartSite 10013186BD Switzerland Sàrl · Set, administration, intravascular1 recall2 reports
- Alaris 10863358BD Switzerland Sàrl · Set, administration, intravascular1 recall0 reports
Product lines
Other products in the same recall event
The FDA groups related products into one recall event (event 97067).
- Z-2179-2025 · Open, ClassifiedBD Alaris Pump Module Model, 8100 with Guardrails, Suite MX software versions
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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