Cook Medical recalled 8,750 units of its Roadrunner UniGlide Hydrophilic Wire Guides, which are used to deliver percutaneous catheters into the peripheral vasculature.
The company initiated the recall after receiving a report from DSM Biomedical, which supplies the hydrophilic coating for the wire guides. DSM Biomedical said the wire guides could have been potentially contaminated by 4 to 280 µm glass particles.
Although Cook Medical did not receive any adverse event reports, the company said glass particles could have passed through during processing and could be in the coating of the wire guides. The contamination could lead to adverse events such as vessel damage, bleeding and embolic particulate in the circulatory system, according to Cook Medical.
This is the latest in a series of recalls for Cook Medical. The company recalled all lots of catheters with its Beacon Tip technology in May and 360 lots of its single lumen central venous catheters and pressure monitoring sets and trays in February.