Cook Medical announced a global recall of 8,750 units of its Roadrunner UniGlide hydrophilic wire guides due to the possibility of glass particles in the coating of the wire guide units.
Netherlands-based DSM Biomedical B.V., Cook Medical’s supplier of the hydrophilic coating for the wire guides, recalled certain lots of material due to concerns about glass particles ranging in size from 4 to 280 µm.
Cook received one lot of the affected recalled coating, which prompted the company to initiate the global recall. The company said it was taking the action as a precautionary measure.
The wire guides deliver percutaneous catheters into the peripheral vascular system. Potential adverse events could include vessel damage, bleeding and embolic particulate in the circulatory system. Cook Medical has not received any reports of adverse events.
Cook requested customers and distributors to quarantine and discontinue use of all recalled units. For a full list of affected products and lot numbers, read the notice here: www.fdanews.com/08-19-16-Cookrecall.pdf. — Tamra Sami