Class 1 Recall: Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination
Cook Medical’s supplier of hydrophilic coating for the Roadrunner Uniglide Hydrophilic Wire Guide recalled certain lots of material because of a potential contamination by glass particles.
Tue Sep 06 2016
Class 1 Recall: Cook Medical Recalls Roadrunner® UniGlide® Hydrophilic Wire Guide Because of Potential Coating Contamination
The FDA has identified this as a Class I recall, the most serious type of recall. Use of these devices may cause serious injuries or death.
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
- Complete list of affected devicesdisclaimer icon
- Devices recalled in the U.S.: 8,750 units
Device Use
The Roadrunner UniGlide Hydrophilic Wire Guide is intended for use by physicians to insert catheters through the skin into the peripheral vasculature system, which consists of veins and arteries not in the chest or abdomen.
Reason for Recall
Cook Medical’s supplier of hydrophilic coating for the Roadrunner Uniglide Hydrophilic Wire Guide recalled certain lots of material because of a potential contamination by glass particles. Cook received one lot of the affected recalled coating. Cook is taking this action as a precautionary measure, because it cannot guarantee that there are no glass particles 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.
Who May be Affected
- Hospitals and health care providers using the Roadrunner UniGlide Hydrophilic Wire Guide
What to Do
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 cookmedical4502@stericycle.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.
Adverse events or quality problems experienced with the use of this product may also be reported to FDA:
- Online at https://www.fda.gov/Safety/MedWatch/HowToReport/default.htm (form available to fax or mail), or
- By phone at 1-800-FDA-1088
Cook communicated this information to its customers in an Urgent Medical Device Recall letter on June 24, 2016.
Contact Information
Customers with medical questions or concerns should contact Cook Medical Customer Relations at 800-457-4500 or 812-339-2235. For information regarding the recall, please contact Stericycle Expert Solutions at 866-912-9552.
Date Recall Initiated:
June 24, 2015