Cook Medical Issues Global Recall of Hydrophilic Wire Guides Due to Raw Materials Issue
The recalled wire guides may be contaminated with glass particles
Cook Medical has initiated a recall affecting approximately 8,750 Roadrunner UniGlide Hydrophilic Wire Guides that were distributed globally.
The recall comes after DSM Biomedical, Cook Medical's supplier of hydrophilic coating for the wire guides in question, announced that it was recalling certain lots of material due to concerns of potential contamination by glass particles.
Cook received one lot of the coating product recalled by DSM for use in the manufacture of the Roadrunner UniGlide Hydrophilic Wire Guides. The company says that it is taking this action 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.
Potential adverse events that may occur as a result of this contamination include vessel damage, bleeding and embolic particulate in the circulatory system. To date, Cook Medical has not received any reports of adverse events related to this recall.
The Roadrunner UniGlide Hydrophilic Wire Guide is intended for use in the delivery of percutaneous catheters into the peripheral vasculature.
For a full list of affected products and lot numbers, see the FDA release. The recalled wire guides can be identified by the part number and lot number on the outer label of the package.
Cook Medical has notified its customers and distributors by recall notification letters. The letters requested that all customers and distributors quarantine and discontinue use of all recalled units and return the products to Cook as soon as possible for credit.
Consumers with questions or concerns about this recall can contact Cook Medical Customer Relations at (800) 457-4500.