CLASS I ONGOING Device recall · Reported 15 Oct 2025 · FDA Enforcement Report
BD Alaris Pump Infusion Sets recalled by CareFusion 303
CareFusion 303 is recalling BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, distributed nationwide in the US. The recall was initiated on 11 Sep 2025 and the FDA has classified it as Class I.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0035-2026
- FDA event ID
- 97519
- Recalling firm
- CareFusion 303, San Diego, CA
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 11 Sep 2025
- FDA classified
- 8 Oct 2025
- Reported
- 15 Oct 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Device Malfunction
- Device type
- Infusion Pumps
Timeline
| 11 Sep 2025 | Recall initiated by company | |
| 8 Oct 2025 | Classified by FDA | +27 days |
| 15 Oct 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Device recalls are issued when a component, software or design fault could cause the device to fail or give wrong readings. Many are corrections applied in the field rather than physical returns.
Product as listed by the FDA
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
Where it was distributed
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
Questions about this recall
Why was it 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.
Which lots are affected?
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
Where was it sold?
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
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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Other Infusion Pumps recalls
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|---|---|---|---|---|---|
| Device | CLASS I | BD Alaris Pump Infusion Sets 10561554* recalled by BD Switzerland Sarl | BD Switzerland Sarl | Other | Nationwide |
| Device | CLASS II | IV Non-Dedicated Gravity Administration Sets with drip chambers recalled | ICU Medical | Foreign Material | Nationwide |
| Device | CLASS II | Plum administration sets recalled by ICU Medical | ICU Medical | Particulate Matter | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump, Loaner recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |
| Device | CLASS II | Baxter Novum IQ Syringe Pump recalled by Baxter Healthcare | Baxter Healthcare | Device Malfunction | Nationwide |