Cook Medical Catheter Wire Guide Recall Issued Over Raw Materials Problem
Due to a risk of potential contamination with glass particles, a global recall has been issued for Cook Medical Roadrunner UniGlide wires, which are used with percutaneous catheters.
The Roadrunner UniGlide Hydrophilic Wire Guides recall was announced by the FDA on August 15.
The wire guides are manufactured by Cook Medical, and one of its materials suppliers, DSM Biomedical B.V., based in the Netherlands, has informed the company that there is a hazard of glass particle contamination.
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The device is used to get percutaneous catheters into the peripheral vasculature. DSM makes the hydrophilic coating for the recalled wire guides. Glass in the coating can cause blood vessel damage, bleeding and could result in an embolism in the circulatory system, the FDA warns.
There have been no reports of injuries or incidents related to the recall.
The recall affects 8,750 Roadrunner UniGlide Hydrophilic Wire Guides sold world wide. A full list of affected products and lot numbers is located in the recall notice. The part number and lot number are located on the outer label of the package.
In addition to the recall, Cook Medical indicates that it has notified customers and distributors through recall notification letters that request all customers and distributors quarantine and discontinue use of the recalled units. Cook is asking for the devices to be returned as soon as possible in exchange for credit.
Consumers with medical questions can contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235. Customers with recall specific questions can contact Stericycle Expert Solutions at 1-866-912-9552.
The FDA request that adverse event reports be submitted to the FDA’s MedWatch program.
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