UPDATED 09/06/2016 Recall classified as Class I
Recalled Device and Discontinuation of the Product line
- All serial and lot numbers of the Roadrunner® UniGlide® Hydrophilic Wire Guide
- Manufacturing and distribution dates: Affected devices were distributed between May 2, 2016 and June 17, 2016
Cook Medical provided the following recommendations for facilities that received an affected device:
- Examine inventory immediately to determine if you have affected products and quarantine affected products.
- Return affected products to Stericycle Expert Solutions (a third-party recall administration service provider). Use the label included in the medical device recall notice and a copy of the Acknowledgement and Receipt Form to receive a product credit.
- Even if you do not have affected products on hand, you must still complete the Acknowledgement and Receipt Form and fax it to 866.796.4780 or email it to email@example.com.
- Report adverse events to Cook Medical Customer Relations at 800.457.4500 or 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.
AUDIENCE: Cardiology, Risk Manager
ISSUE: 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.
BACKGROUND: 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 can be found in the recall notice. 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.
RECOMMENDATION: 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.
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.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.