CareFusion recalls BD Alaris Pump Module REF 8100 due to user manual error that may cause accidental overinfusion if safety clamp is left open. Affected units include those with software version 12.1.2.
Due to User Manual/Direction for Use incorrectly instructing user to leave the safety clamp in the open position when reloading an infusion set. This issue potentially could result in an accidental over infusion if the roller clamp is left open.
CareFusion is recalling BD Alaris Pump Module REF 8100 because the user manual incorrectly instructs users to leave the safety clamp open when reloading infusion sets. This could lead to accidental overinfusion of fluids, which may cause injury.
The user manual incorrectly states to leave the safety clamp open when reloading infusion sets. If the clamp remains open, the pump could deliver too much fluid, causing overinfusion. This is a potential safety hazard during fluid administration.
Adults, children, and newborns using the BD Alaris System with Guardrails Suite MX for fluid administration are likely affected. Patients using the pump with the specific software version 12.1.2 are at most risk.
Check for the BD Alaris Pump Module REF 8100 with software version 12.1.2. The product is sold under CareFusion and used for continuous or intermittent fluid administration in medical settings.
Ensure the safety clamp is fully closed before reloading an infusion set to prevent accidental overinfusion.
The product is safe to use if the safety clamp is properly closed before reloading an infusion set. The user manual error does not require immediate discontinuation.
The official recall does not specify a remedy, so users should check the safety clamp position before each use to prevent overinfusion.
Check for the BD Alaris Pump Module REF 8100 with software version 12.1.2. The product is used for continuous or intermittent fluid administration in medical settings.
We’ve drafted a message you can send CareFusion to request your refund or repair — edit it as you like.
Subject: Recall Z-1231-2025 — CareFusion CareFusion Hello, I own a CareFusion that is covered by recall Z-1231-2025 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.
