Class I Recall of Becton Dickinson CareFusion Pumps
USA- Reuters.com writes that the Food and Drug Administration (FDA) has issued a recall of certain Becton Dickinson CareFusion Pumps. The pumps are defective due to a problem with the software and the system. The Administration classified this recall as Class I. Class I recalls are only issued in the most severe cases.*
The recall applies to 774,000 units of the Alaris System Pumps that were sold in the United States. So far, there have been 55 injuries resulting from the defect and one reported fatality.
The recalled device is used to infuse substances into patients and to monitor the person's vital signs. The pumps may deliver fluids, blood, or medication and are intended to do so in carefully controlled amounts. The systems are used by pumping through tubing into the person's veins or another route. Patients of all ages, including adults, children, and neonatal individuals, may be treated with the use of the device. Hospitals and other medical facilities use these pumps.
The FDA has three classes of recalls. Class I recalls are the most severe. In order for the Administration to issue a Class I recall, the product must present a risk of serious or fatal injuries.
Customers who have purchased the system are being instructed to contact the FDA's MedWatch using an online form, or through mail or fax.
The company will be providing a software update to repair the issues with the device. Any medical facilities with questions regarding the problems can contact the company. Additional information can be located on the Becton Dickinson website.
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Sources:https://www.reuters.com/article/brief-fda-says-becton-dickinson-carefusi/brief-fda-says-becton-dickinson-carefusion-303-recalls-alaris-system-infusion-pumps-due-to-software-system-errors-idUSFWN2AZ0AO and https://www.fda.gov/medical-devices/medical-device-recalls/becton-dickinson-bd-carefusion-303-inc-recalls-alaris-system-infusion-pumps-due-software-and-system