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August 16, 2016
3 Min Read
Contaminated coating could cause vessel damage, bleeding, and blood clot particles in the circulatory system.
Roadrunner UniGlide Hydrophilic Wire Guides (Image courtesy of Cook Medical)
Cook Medical is recalling thousands of guidewires whose coating may be contaminated with glass particles.
The Dutch company DSM Biomedical B.V., which supplies the coating for the Roadrunner UniGlide Hydrophilic Wire Guides, issued its own recall and alerted Cook to the possible presence of glass in the coating, according to a statement from Cook. Cook said it voluntarily initiated the recall on June 24 as a precautionary measure, in case glass particles passed through during processing. The guidewires are used during delivery of percutaneous catheters to the peripheral vasculature, and the coating eases tracking and pushing, according to the Cook website.
The glass particles range in size from about 4 microns to 280 microns. Cook said it received one lot of the affected recalled coating, and recalled 8750 Roadrunner guides distributed globally. Potential adverse events include vessel damage, bleeding, and the presence of blood clot particles in the circulatory system. Cook said it has not received any reports of such events, and none were reported to FDA. The agency has yet to classify the severity of the recall. A list of affected lots is included in the statement from Cook.
Cook customers and distributors have been notified via letter, and have been asked to quarantine and discontinue use of all recalled units and return the affected products to Cook as soon as possible for credit. FDA and other regulatory agencies around the world have been notified of this action.
It's the latest setback for the Bloomington, IN-based medical device company, which announced in April that it was voluntarily recalling about 4.1 million of its catheters with Beacon Tip technology because of complaints of the tips splitting or fracturing during procedures. The April recall expanded on a much smaller 2015 recall that involved 95,167 devices. Cook officials decided to recall all lots and sizes of the catheters to "assure patient safety."
Cook suffered another major catheter recall in February, involving 360 lots of single lumen central venous catheters and pressure monitoring sets and trays, or 17,827 devices globally. In that case, there was a potential for catheter tip fracture and/or separation. The company found that the technique used by the product assembler while adding the tip to the catheter likely contributed to the problem.
Nancy Crotti is a contributor to Qmed.
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