CareFusion 303, Inc. is recalling 242,098 BD Alaris Pump Modules (Model 8100) because the user manual provides incorrect instructions for reloading infusion sets. The manual mistakenly tells users to leave the safety clamp in the open position, which can lead to accidental over-infusion of fluids or medications. If you use these devices, you should contact the manufacturer or your distributor immediately to receive corrected instructions or arrange for a system update.
The incorrect manual instructions may cause a roller clamp to be left open while reloading the pump, potentially leading to an uncontrolled delivery of medication or fluids. This over-infusion poses a serious risk of patient harm or life-threatening complications, though no injuries have been reported to date.
Recall affects BD Alaris System with Guardrails Suite MX; serial and lot numbers are currently pending.
If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.
This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.
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Sources: FDA iRES · Raw API Response
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