CareFusion recalls Model 8100 Alaris Pump Module software versions 12.1.0 and older due to potential therapy interruptions and incorrect medication concentrations.
1)Error 255-XX-XXX results in inability to edit settings 2)Delay options programming may result in no KVO rate/therapy interruption 3)Software errors results in no low battery alarm/infusion stopping 4)Medium priority KVO/End of Infusion alarms may result in unrecognized infusion completion 5)Custom concentration data entry errors results in concentrations being lower/higher than medication orders
CareFusion is recalling Alaris Pump Module Model 8100 with specific software versions because errors can cause therapy interruptions or incorrect medication concentrations. This affects people using insulin pumps who rely on precise dosing.
The software errors can cause the pump to stop delivering insulin, miss low battery warnings, or show incorrect medication concentrations. This may lead to therapy interruptions or incorrect dosing levels.
People using CareFusion Alaris Pump Model 8100 with software versions 12.1.0 or older are affected. Those with diabetes who rely on continuous insulin delivery are most at risk.
Check if your pump has the model number 8100 and software versions 12.1.0 or older. The recall covers specific software versions, not all pumps.
Look for the software version on your pump's display or in the pump's settings menu.
Contact CareFusion to get the latest software update if your version is outdated.
No, the recall does not require immediate stop use. You can continue using the pump but should update the software.
Software versions 12.1.0 and older (including 9.33) are affected.
Contact CareFusion directly for software updates. The recall does not specify a deadline for updates.
We’ve drafted a message you can send CareFusion to request your refund or repair — edit it as you like.
Subject: Recall Z-1360-2020 — CareFusion CareFusion Hello, I own a CareFusion that is covered by recall Z-1360-2020 from CareFusion. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
