On January 6, 2016, Cook Medical initiated a voluntary recall of 360 specific lots of Single Lumen Central Venous Catheters and Pressure Monitoring Sets and Trays due to catheter tip fracture and/or separation. Globally, 17,827 devices are subject to this recall.
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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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