FDAnews Device Daily Bulletin
Medical Devices / Postmarket Safety

Cook Medical Issues Recall of Catheter Wires Due to Raw Materials Issue

Aug. 15, 2016
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Cook Medical is recalling 8,750 units of its Roadrunner Uniglide Hydrophilic Wire Guide due to concerns about potential contamination by glass particles.

The recall was prompted by another recall initiated by one of the company’s suppliers, DSM Biomedical, over the issue.

The product is intended for use in the delivery of percutaneous catheters into the peripheral vasculature. — Cynthia Jessup

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