Medical Device Safety and Recalls: Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination

["U.S. Food & Drug Administration (FDA)" <fda@xxxxxxxxxxxxxxxxxxxxxxx>]

Title: Medical Device Safety and Recalls: Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination

Cook Medical’s supplier of hydrophilic coating for the Roadrunner Uniglide Hydrophilic Wire Guide recalled certain lots of material because of a potential contamination by glass particles. Cook received one lot of the affected recalled coating. Cook is taking this action as a precautionary measure, because it cannot guarantee that there are no glass particles in the coating of the recalled wire guide units. Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system.

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