DSM Biomedical B.V., the Netherlands, Cook Medical’s supplier of hydrophilic coating for the Roadrunner Uniglide Hydrophilic Wire Guide, recalled certain lots of material due to concerns about a potential contamination by glass particles ranging in size of approximately 4 to 280 µm. Cook received one lot of the affected recalled coating. This prompted Cook Medical to initiate a recall of 8,750 units of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016. Cook 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 could include vessel damage, bleeding and embolic particulate in the circulatory system. Cook Medical has not received any reports of adverse events of these types to date.
The Roadrunner UniGlide Hydrophilic Wire Guide is intended for use in the delivery of percutaneous catheters into the peripheral vasculature.
A full list of affected products and lot numbers is attached. Products can be identified by the part number and lot number on the outer label of the package. Products in this recall were distributed globally.
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 affected products to Cook as soon as possible for credit.
The FDA and other regulatory agencies around the world have been notified of this action.
Consumers with medical questions or concerns should contact Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time. For information regarding the recall, please contact Stericycle Expert Solutions at 1-866-912-9552.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report online at www.fda.gov/medwatch/report.htm or via regular mail or fax. Download the form at www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, and then complete and return to the address on the preaddressed form, or submit by fax to 1-800-FDA-0178.
Adverse events may also be reported to Cook Medical Customer Relations at 1-800-457-4500 or 1-812-339-2235, Monday through Friday, between 7:30 a.m. and 5:00 p.m. Eastern time or by email at CustomerRelationsNA@cookmedical.com.