August 16, 2016

FDA: Cook Medical recalls Roadrunner UniGlide Hydrophilic Wire Guides

By: Judy Mathias
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Editor's Note

The Food and Drug Administration (FDA) on August 15 announced the recall by Cook Medical (Bloomington, Indiana) of 8,750 units of its Roadrunner UniGlide Hydrophilic Wire Guides because of concerns about a potential contamination of the wires’ hydrophilic coating with glass particles.

The wire guides are used in the delivery of percutaneous catheters into the peripheral vasculature.


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Posted 08/15/2016] AUDIENCE: Cardiology, Risk Manager ISSUE: 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.

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