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COMPANY ANNOUNCEMENT

Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue

When a company announces a recall, market withdrawal, or safety alert, the FDA posts the company's announcement as a public service. FDA does not endorse either the product or the company.

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Cook Medical Issues Global Recall of Roadrunner® UniGlide® Hydrophilic Wire Guides due to raw materials issue

Summary

Company Announcement Date:
August 15, 2016
FDA Publish Date:
November 03, 2018
Reason for Announcement:
Company Name:
Cook Medical
Brand Name:
Brand Name(s)
Roadrunner
Product Description:
Product Description
Roadrunner UniGlide Hydrophilic Wire Guides

Company Announcement

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.

RPNGPNAffected Lot Numbers
HPW-35-150G561496911533, 6911535, 6935851, 6968779, 6981351, 6986897, 6986898, 7000733
HPW-35-180G561506981026, 6981346
HPWA-18-180G561607000727, 7000730, 7000735, NS6999761
HPWA-18-260G304896935843, 6935846, 6948858, 6965469, 6981347, NS6948859
HPWA-18-320G304906911545, 6981349, 7015899
HPWA-25-260G304917015857, 7019022, 7019027
HPWA-35-150G561736911529, 6911530, 6948854, 6948855, 6948855X, 6948856, 6955232, 6955233, 6955234, 6955234X,
6955235, 6961754, 6961756, 6961757, 6961758, 6965625, 6965626, 6968777, 6975365, 6981022,
6995077, 6995078, 6995080, 7012528, 7012529, NS6975369, NS6981025, NS6995079, NS7000728
HPWA-35-180G561746911522, 6911523, 6911524, 6911526, 6911527, 6911528, 6935844, 6955228, 6955229, 6955230,
6955231, 6965235, 6965236, 6965237, 6965238, 6975367, 6975368, 6988487, 6988488, 7015853,
7015854, 7016252, 7016253, 7019017, 7019018, 7019491, 7019492, 7019493, 7019494, 7021223,
7021225, 7021226, 7021227, NS6911520, NS6935845, NS6935847, NS7019495
HPWA-35-260G304926948857, 6961759, 6965240, 6986896, 7000724, 7000725, 7000726, 7012840, 7019019, 7019020, NS6965239, NS6968778, NS6999757, NS6999758, NS7012841, NS7019023, NS7019024
HPWA-35-80G561726948860
HPWAS-35-150G561766919676, 6919680, 6935853, 6935855, 6961761, 6995082, 6995083, 7022591, NS6935854
HPWAS-35-180G561776961752, 6961753, 7012526, 7012527, 7015855, 7015856, 7021222, 7021224
HPWAS-35-260G305066911549, 6911551, 6911552, 6919678, 6935848, 6935849, 6935850, 6935852, 6948861, 6948862,
6955236, 6955237, 6997860, 7000732, 7015897, 7015898, 7019025
HPWS-35-150G561526961755, 6961760, 6999760
HPWS-35-180G561536992197, 6992198, 6999759, 7012530

 

Consumers

Cook Medical Customer Relations
CustomerRelationsNA@cookmedical.com
1-800-457-4500 or 1-812-339-2235

Media

Marsha Lovejoy, Global Manager,
Corporate Content Strategy
marsha.lovejoy@cookmedical.com
1-812-339-2235 ext. 2750