BD Alaris Pump Infusion Sets for the following reference… recallZ-0035-2026 · CareFusion 303, Inc. · initiated Sep 11, 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 Email 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-0035-2026
- Status
- Open, Classified
- Initiated by the company
- Sep 11, 2025
- Posted by the FDA
- Oct 8, 2025
- Recalling firm
- CareFusion 303, Inc.
- Product code
- FPA
- FDA submissions
- K022209
- Distribution
- US: Nationwide OUS: United Arab Emirates Australia Belgium Bahrain Botswana Canada Switzerland China France United Kingdom Gibraltar Israel India Kuwait Mexico Malaysia Netherlands New Zealand Philippines Pakistan Qatar Saudi Arabia Singapore Taiwan, Province of China South Africa
Product description
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-Site 10015414, 180 Micron Filter 2447-0007, Ball Valve SmartSite Port (Burette) 2 SmartSites Y-Sites 24201-0007, 2 SmartSite Y-sites 10012645, Back Check Valve, Non-vented, SmartSite Y-site 2426-0500, Back Check Valve, 3 SmartSite Y-sites 2450-0500, Check Valve 2 Ganged 3-Way Stopcocks 3 SmartSite Y-sites 11522558, Ball Valve, Back Check Valve, 3 SmartSite Y-sites 2410-0500, 2 SmartSite Y-Sites 2232-0007, 0.2 Micron Filter 11613191, 0.2 Micron Filter, Ball Valve, SmartSite" Port (Burette), 2 SmartSite Y-sites 10012144, 3 SmartSite Y-Sites, Check Valve 10013034, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 4-way Stopcock 10013037, Non-Vented, 180 Micron Filter, Low Sorbing Tubing Segment, 1 SmartSite, Y-Site 11582773, 3 SmartSite Y-Sites, Check Valve, 2-Ganged 3-way Stopcock
Code information (models, lots, serial numbers)
All Lots/ UDI: C24101E - 10885403235528, 10015414 - 10885403233999, 2447-0007 - 10885403235078, 24201-0007 - 10885403476341, 10012645 - 10885403233753, 2426-0500 - 7613203020992, 11522558 - 10885403232305, 2410-0500 - 7613203012492, 2232-0007 - 10885403463969, 11613191 - 10885403276026, 10012144 - 7613203021159, 10013034 - 10885403232312, 10013037 - 10885403233784, 11582773 - 10885403239588
Devices named in this recall
14 devices in the FDA device registry whose identifier appears in the recall's code information.
- Alaris, SmartSite 2426-0500BD Switzerland Sàrl · Set, administration, intravascular2 recalls4 deaths753 reports
- Alaris, SmartSite 11522558BD Switzerland Sàrl · Set, administration, intravascular2 recalls124 reports
- Alaris 10015414BD Switzerland Sàrl · Set, administration, intravascular2 recalls96 reports
- Alaris, SmartSite 10012144BD Switzerland Sàrl · Set, administration, intravascular2 recalls18 reports
- Alaris, SmartSite 11613191BD Switzerland Sàrl · Set, administration, intravascular2 recalls0 reports
- Alaris, SmartSite C24101EBD Switzerland Sàrl · Set, administration, intravascular1 recall30 reports
- Alaris 2232-0007BD Switzerland Sàrl · Set, administration, intravascular1 recall19 reports
- Alaris, SmartSite 2447-0007BD Switzerland Sàrl · Set, administration, intravascular1 recall7 reports
- Alaris, SmartSite 2410-0500BD Switzerland Sàrl · Set, administration, intravascular1 recall4 reports
- Alaris, SmartSite 10012645BD Switzerland Sàrl · Set, administration, intravascular1 recall4 reports
- Alaris, SmartSite 10013034BD Switzerland Sàrl · Set, administration, intravascular1 recall3 reports
- Alaris, SmartSite 10013037BD Switzerland Sàrl · Set, administration, intravascular1 recall2 reports
- Alaris, SmartSite 11582773BD Switzerland Sàrl · Set, administration, intravascular1 recall0 reports
- Alaris 24201-0007BD Switzerland Sàrl · Set, i.V. Fluid transfer1 recall0 reports
Product lines
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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