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U.S. Department of Health and Human Services

Class 1 Device Recall Roadrunner Uniglide Hydrophilic Wire Guide

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  Class 1 Device Recall Roadrunner Uniglide Hydrophilic Wire Guide see related information
Date Initiated by Firm June 24, 2016
Date Posted August 25, 2016
Recall Status1 Terminated 3 on November 01, 2017
Recall Number Z-2537-2016
Recall Event ID 74561
510(K)Number K110009  K130766  
Product Classification Wire, guide, catheter - Product Code DQX
Product Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177.
Used with vascular catheter.
Roadrunner UniGlide Hydrophilic Wire Guide is constructed from a steerable, metallic core with a polymer coating. A hydrophilic coating is applied over the radiopaque polymer jacket. Sterile- Individual product is packaged in a Tyvek-film sterilizable outer pouch and boxed in a quantity of five.
Code Information Roadrunner Uniglide Hydrophilic Wire Guide, Catalog Numbers and GPN: HPWA-18-260, G30489; HPWA-18-320, G30490; HPWA-25-260, G30491; HPWA-35-260, G30492; HPWAS-35-260, G30506; HPW-35-150, G56149; HPW-35-180, G56150; HPWS-35-150, G56152; HPWS-35-180, G56153; HPWA-35-80, G56172; HPWA-35-150, G56173; HPWA-35-180, G56174; HPWA-18-180, G56160; HPWAS-35-150, G56176; HPWAS-35-180, G56177.   Lot numbers 6911522, 6911523, 6911524, 6911526, 6911527, 6911528, 6911529, 6911530, 6911533, 6911535, 6911545, 6911549, 6911551, 6911552, 6919676, 6919678, 6919680, 6935843, 6935844, 6935846, 6935848, 6935849, 6935850, 6935851, 6935852, 6935853, 6935855, 6948854, 6948855, 6948856, 6948857, 6948858, 6948860, 6948861, 6948862, 6955228, 6955229, 6955230, 6955231, 6955232, 6955233, 6955234, 6955235, 6955236, 6955237, 6961752, 6961753, 6961754, 6961755, 6961756, 6961757, 6961758, 6961759, 6961760, 6961761, 6965235, 6965236, 6965237, 6965238, 6965240, 6965469, 6965625, 6965626, 6968777, 6968779, 6975365, 6975367, 6975368, 6981022, 6981026, 6981346, 6981347, 6981349, 6981351, 6986896, 6986897, 6986898, 6988487, 6988488, 6992197, 6992198, 6995077, 6995078, 6995080, 6995082, 6995083, 6997860, 6999759, 6999760, 7000724, 7000725, 7000726, 7000727, 7000730, 7000732, 7000733, 7000735, 7012526, 7012527, 7012528, 7012529, 7012530, 7012840, 7015853, 7015854, 7015855, 7015856, 7015857, 7015897, 7015898, 7015899, 7016252, 7016253, 7019017, 7019018, 7019019, 7019020, 7019022, 7019025, 7019027, 7019491, 7019492, 7019493, 7019494, 7021222, 7021223, 7021224, 7021225, 7021226, 7021227, 7022591, 6948855X, 6955234X, NS6911520, NS6935845, NS6935847, NS6935854, NS6948859, NS6965239, NS6968778, NS6975369, NS6981025, NS6995079, NS6999757, NS6999758, NS6999761, NS7000728, NS7012841, NS7019023, NS7019024, and NS7019495.
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Stericycle Expert Solutions
866-912-9552
Manufacturer Reason
for Recall		 Potential coating contamination with glass particles.
FDA Determined
Cause 2		 Material/Component Contamination
Action Cook Inc. initiated a voluntary recall of the Roadrunner UniGlide Hydrophilic Wire Guides on June 24, 2016 via courier due to the potential for the device to be contaminated with glass particles. The firm issued a press release dated August 12, 2016. Customers were asked to take the following actions: 1. Examine inventory immediately to determine if you have affected products and quarantine affected products. 2. Return affected products to Stericycle Expert Solutions (a third-party recall administration service provider). Use the enclosed label and a copy of the Acknowledgement and Receipt Form to receive a product credit. 3. 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. 4. 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. Should you have any medical questions or concerns, please 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. Cook is providing notification to distributors and informing them that this notice must be shared with appropriate personnel, including down to the user level, within your organization or to any organization where the potentially affected devices have been transferred.
Quantity in Commerce 8,750 devices were distributed in commerce
Distribution Worldwide distribution. US (nationwide), Australia, Austria, Belgium, Canada, China, Czech Republic, France, Germany, Hong Kong, Hungary, Italy, Jordan, Korea, Spain, South Africa, Taiwan, Turkey, and United Kingdom
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = COOK, INC.
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