DUBLIN – Medtronic is notifying customers worldwide of a voluntary recall for the battery pack used in its Covidien Oridion labeled Capnostream™20 and Capnostream™20p Patient Monitors. This voluntary recall is being conducted due to a battery manufacturing defect that may increase the risk of thermal damage in the battery pack.
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The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
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