August 25, 2012 — The U.S. Food and Drug Administration (FDA) has issued a voluntary Class 1 recall of the CareFusion infusion pump — including the CareFusion 303, Alaris Pump Module, Model 8100. According to the FDA, the problem is that the keypad covering could become loose or peel away, which might allow fluid to enter the device. If the keypad malfunctions, the infusion device could malfunction and cause an alarm to go off. A malfunctioning CareFusion infusion pump could cause severe injury or death to the patient.
The CareFusion infusion pump is a medical device that is used to mechanically pump fluids, including blood, drugs, and blood products. The device delivers these fluids in many ways, including intravenous, epidural, intra-arterial, and more. The affected products were manufactured between October 2011 and February 2012.
CareFusion has already taken action by sending a recall notification letter to each affected customer and distributor. People who have purchased the CareFusion infusion pump are advised to visually inspect the device for obvious signs that the keypad covering has detached or loosened, which might allow fluid to enter the device.
This is the second Class 1 recall of a CareFusion infusion pump this month. The FDA announced another recall of the Alaris PC unit Model 8015 due to a malfunction with the product’s power supply board.
Class 1 recalls are the most serious type of recall the FDA can initiate. They are reserved for scenarios where a safety issue is highly likely to cause severe injury or death.
Do I have a CareFusion Infusion Pump Lawsuit?
The Schmidt Firm, PLLC is currently accepting CareFusion Infusion Pump induced injury cases in all 50 states. If you or somebody you know has been injured by CareFusion Infusion Pump, you should contact our lawyers immediately for a free case consultation. Please use the form below to contact our Defective Medical Device Litigation Group or call toll free 24 hours a day at (866) 920-0753.
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