FDA: Global Recall for Roadrunner UniGlide Wire Guides After Coating Contaminated
Cook Medical is recalling the Roadrunner UniGlide wire guides after particles of glass were discovered in the hydrophilic coating, according to an announcement from the US Food and Drug Administration earlier this week.
The company issued the recall of the Roadrunner wire guides, which are used to guide percutaneous catheters into the peripheral vasculature, on June 24, 2016, after DSM Biomedical, the company that makes the hydrophilic coating, discovered the contamination in their production process.
DSM Biomedical recalled the lots of the affected coating, which led to Cook Medical recalling 8,750 units of the Roadrunner wire guide “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.”
The potential adverse events resulting from the glass particles, which range in size from 4 to 280 µm, include vessel damage, bleeding, and embolic particulate in the circulatory system. Cook Medical is asking all customers and distributors quarantine and discontinue use of the recalled units and return them to the company as soon as possible.
Food and Drug Administration. Roadrunner UniGlide Hydrophilic Wire Guides by Cook Medical: Recall-Raw Materials Issue. http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm516741.htm. Published on: August 15, 2016. Accessed on: August 17, 2016.