Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system. Cook Medical has not received any reports of adverse events of these types to date.
Showing posts with label hydrophilic coating. Show all posts
Showing posts with label hydrophilic coating. Show all posts
18 August, 2016
Cook Medical Issues Global Recall of Hydrophilic Wire Guides
DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner® Uniglide® Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016. Cook is taking this action as a precautionary measure, because it cannot exclude the possibility that glass particles passed through during processing and could be present 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. Cook Medical has not received any reports of adverse events of these types to date.
Potential adverse events that may occur as a result of this contamination could include vessel damage, bleeding and embolic particulate in the circulatory system. Cook Medical has not received any reports of adverse events of these types to date.
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