FDA classifies recall of Roadrunner UniGlide Hydrophilic Wire Guides as Class I

Editor's Note

The Food and Drug Administration (FDA) on September 6 classified the recall of the Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical (Bloomington, Indiana) as Class I, the most serious.

All serial and lot numbers are being recalled, and the product line is being discontinued because of concern of contamination by glass particles in the wire guides’ hydrophilic coating.

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

The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.