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U.S. Department of Health and Human Services

Class 2 Device Recall Cook Roadrunner UniGlide Hydrophilic Wire Guide

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  Class 2 Device Recall Cook Roadrunner UniGlide Hydrophilic Wire Guide see related information
Date Initiated by Firm July 19, 2022
Create Date September 09, 2022
Recall Status1 Open3, Classified
Recall Number Z-1710-2022
Recall Event ID 90710
510(K)Number K110009  
Product Classification Wire, guide, catheter - Product Code DQX
Product Roadrunner UniGlide Hydrophilic Wire Guide

REFERENCE PART NUMBER (RPN): HPW-35-150
ORDER NUMBER (GPN):G56149. For vascular catheter positioning and exchange in diagnostic and interventional procedures.
Code Information UDI-DI: (01)00827002561496- Lot Numbers: 14070921, 14108915, 14108916, 14129152, 14141997, 14170230
Recalling Firm/
Manufacturer		 Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook Medical Customer Relations Department
800-457-4500
Manufacturer Reason
for Recall		 Product did not meet the acceptance criteria for packaging testing, which included 3-year age acceleration testing, therefore, the sterility of the device may be compromised.
FDA Determined
Cause 2		 Under Investigation by firm
Action Cook notified consignees by Urgent Medical Device Recall Letter on July 19, 2022. Letter states reason for recall, health risk and action to take: Examine inventory immediately to determine if you have affected product(s) and quarantine any affected product that remains unused. Immediately cease all further distribution and use of the affected products. 2. Return the affected product(s) to Cook Medical with a copy of the Acknowledgement and Receipt Form to receive a product credit. Refer to the Acknowledgement and Receipt Form for return instructions. 3. Please complete the Acknowledgement and Receipt Form within 5 business days of receiving this letter regardless of whether you have affected product(s) on hand. You may return the Form via fax (812.339.7316) or email (FieldActionsNA@CookMedical.com). 4. This notice must be shared with appropriate personnel, including down to the user level, within your organization or with any organization where the potentially affected devices have been transferred. 5. Please immediately report adverse events to Cook Medical Customer Relations by phone at 800.457.4500 or 812.339.2235, Monday through Friday between 7:30am and 5:00pm (Eastern Time), or by email to: CustomerRelationsNA@CookMedical.com.
Quantity in Commerce 585 units
Distribution Nationwide Foreign: AR AT AU BE BG CA CA CH CL CN CZ DE DK ES FR GB GR GU HU IL IT JO JP KR KW MX MY NC NL PE PL PR PT PY RU SE SI TR UY ZA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = DQX and Original Applicant = COOK, INC.
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