United StatesBD Alaris Pump Infusion Sets (including reference numbers such as C24101E and other listed references/UDIs) are affected and can be recognised by their BD Alaris product name and the specified reference numbers and UDIs. They were recalled because an infusion pump module used with compatible pump infusion sets may perform outside established performance ranges for flow rate and bolus accuracy, downstream and upstream occlusion time to alarm, and post‑occlusion bolus volume.
What's being recalled
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…
Recalling firm: CareFusion 303, Inc., San Diego, CA, United States.
How to identify it
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
The hazard
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.
What to do
Don't stop taking a prescribed medicine without talking to your doctor or pharmacist first. For other products, stop using them and ask the pharmacist, seller or maker what to do.
The notice doesn't give instructions for consumers, so this is general advice for health & beauty recalls. Check the official notice for the details.
Where it was 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
The official notice
This page is a summary of the notice published by U.S. Food and Drug Administration (enforcement reports), collected from U.S. Food and Drug Administration (enforcement reports). Check the original before you act on it.
Read the official notice (opens in a new tab)
Canada