09/21/2020 | Press release | Distributed by Public on 09/21/2020 21:15
When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.Read Announcement
Three Recalls Designated as Class I by FDA; One Designated as Class II
BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today provided an update on previously announced voluntary recalls of the BD Alaris™ System.
Three of the recalls, which BD announced on Aug. 4, 2020, have been designated as Class I recalls by the U.S. Food and Drug Administration (FDA), which means that FDA has determined that there is a reasonable probability that the use of the product will cause serious adverse health consequences or death. One of the situations was designated as a Class II recall, which means use of the product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
BD initiated the voluntary recalls to notify customers of the potential for four hardware situations that may result in the infusion pump not operating as expected. BD has provided instructions to correct and/or mitigate the situations. The four recalls include:
Customers should review and follow the instructions in each of the recall letters listed above.
Note that some affected devices may be branded under the CareFusion name. Customer inquiries related to this action should be addressed to BD's Recall Support Center at 888-562-6018 or [email protected].
FDA MedWatch Reporting
Adverse reactions/events experienced with the use of either of these products should also be reported to the FDA's MedWatch Program by:
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BD is one of the largest global medical technology companies in the world and is advancing the world of health by improving medical discovery, diagnostics and the delivery of care. The company supports the heroes on the frontlines of health care by developing innovative technology, services and solutions that help advance both clinical therapy for patients and clinical process for health care providers. BD and its 65,000 employees have a passion and commitment to help enhance the safety and efficiency of clinicians' care delivery process, enable laboratory scientists to accurately detect disease and advance researchers' capabilities to develop the next generation of diagnostics and therapeutics. BD has a presence in virtually every country and partners with organizations around the world to address some of the most challenging global health issues. By working in close collaboration with customers, BD can help enhance outcomes, lower costs, increase efficiencies, improve safety and expand access to health care. For more information on BD, please visit bd.com.