CareFusion 303, Inc. is recalling 33,162,680 units of the BD Alaris Pump Module Model 8100 and various Alaris Pump Infusion Sets. The infusion pumps and tubing sets may perform outside of their established ranges for flow rate accuracy, bolus accuracy, and occlusion alarms. This means the pumps may deliver more or less medication than intended or fail to alert staff when there is a blockage in the line.
These performance issues can lead to patients receiving an incorrect dose of medication or a delay in therapy when a blockage is not properly detected. This could result in serious patient harm or life-threatening complications due to over-infusion or under-infusion of critical medications.
Recall covers all serial numbers for the specified UDI list.
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 · FDA Press Release · Raw API Response
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