BD Alaris Pump Infusion Sets for the following reference numbers: C24101E, Amber Tubing, 15 Micron
Pending LLM rewrite. Source: FDA_DEVICE Z-0035-2026.
Severity not yet assessed
We have not scored this recall against our rubric yet, so we are not showing a severity rating or our usual guidance. The agency’s own notice below is the authoritative source — read it first.
Plain-English summary
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.
The recalled product
- 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
- Manufacturer
- CareFusion 303, Inc.
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (14)
- 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
Distribution
Distributed nationwide across the United States.
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