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RecallWatchMedical Device Safety
Class IOngoingZ-0035-2026

CareFusion 303, Inc. recalls BD Alaris Pump Infusion Sets for the following reference numbers: C24101E

CareFusion 303, Inc.San Diego, CA, United StatesReported Oct 15, 2025 · 9 months ago
Legal News Analyst ·

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 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
    UDI C24101E
    28 affected lots
    C24101E1088540323552810015414108854032339992447-00071088540323507824201-000710885403476341
    +20 more10012645108854032337532426-0500761320302099211522558108854032323052410-050076132030124922232-0007108854034639691161319110885403276026100121447613203021159100130341088540323231210013037108854032337841158277310885403239588

What the firm 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: DL-US-INF-TechSupport@bd.com.

DistributionShow details

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

Class IWhat this means

A reasonable probability that use of the product will cause serious adverse health consequences or death.

Sources & references

Taylor Coteus
Legal News Analyst

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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