Class I Recall of CareFusion 303, Alaris Pump Module, Model 8100
Published: Aug 23, 2012
The U.S, Food and Drug Administration (FDA) is notifying healthcare professionals of a Class I Recall of the CareFusion 303, Alaris Pump Module, Model 8100, due to a potential for the pump module door keypad overlay to become loose, peel away, or separate from the door assembly. This could cause a potential for fluid ingress which could lead to a keypad malfunction, causing the infusion to stop with alarm. When infusion stops, serious injury or death may result.
The pump module is intended for healthcare facilities that use infusion for the delivery of fluids, drugs, blood, and blood products using continuous or intermittent delivery through intravenous, intra-arterial, subcutaneous, epidural, enteral, or irrigation of fluid spaces routes of administration. The pump module is used for adults, children, and newborns.
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