Cook Medical Recalls Guidewires Due to Potential Glass Contamination

Cook Medical is recalling 8,750 units of its Roadrunner UniGlide Hydrophilic Wire Guides because the coating may be contaminated with glass particles. The company learned about the potential contamination from DSM Biomedical B.V., who supplies the hydrophilic coating and issued a recall of its own. The size of the glass particles ranges from 4 to 280 microns. Injuries that could result from the glass contamination include bleeding, blood vessel damage and blood clots in the circulatory system.

So far, no injuries related to the glass contamination have been reported to Cook or to the U.S. Food and Drug Administration, Cook said in an Aug. 15 recall notice. The company said it issued its voluntary recall on June 24, 2016 as a “precautionary measure, 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.” Cook said it received one lot of guidewires that may be contaminated with glass particles.

Physicians use the guidewires to help place percutaneous catheters into peripheral vasculature.

Customers affected by the recall have been asked to quarantine the affected guidewires and stop using them. Cook asks them to return the products for credit as soon as possible.

Cook announced another recall in April, affecting 4.1 million catheters with Beacon Tip technology. The recall was initiated due to complaints of the tips splitting or fracturing during procedures. This action expanded on a 2015 recall affecting 95,167 units. Cook expanded the recall to include all lots and sizes of catheters.

Another recall was issued in February due to the risk of catheter tip fracture and/or separation. Cook recalled 360 lots of single lumen central venous catheters and pressure monitoring sets and trays, or 17,827 units globally.

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