On July 2, 2015, Cook Medical initiated a lot-specific voluntary recall of 2,239 lots of Beacon Tip Angiographic Catheters. Globally, 95,167 devices are subject to this recall. The products include specific versions and lot numbers of the Torcon NB® Advantage Beacon® Tip Catheters (Catalog Prefix HNBR5.0), Royal Flush® Plus Beacon® Tip High-Flow Catheters (Catalog Prefix HNR4.0), and Slip-Cath® Beacon® Tip Catheters (Catalog Prefix SCBR5.0).
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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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