FDA Device recall Z-0035-2026
BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-S…
- FDA Device
- Class I
- ongoing
- Published 2025-10-15
On 2025-10-15 the FDA classified a Class I recall of BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron Filter, 0.2 Micron Filter, SmartSite Y-S… by Carefusion 303, citing 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 occlu….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0035-2026 |
| Classification | Class I |
| Status | ongoing |
| Initiated | 2025-09-11 |
| Published | 2025-10-15 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Carefusion 303 |
| Distribution | US |
Product
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
Reason
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.
Identifiers
| code_info | All Lots/ UDI: C24101E - 10885403235528, 10015414 - 10885403233999, 2447-0007 - 10885403235078, 24201-0007 - 1088540347…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0035-2026%22
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