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U.S. Department of Health and Human Services

Class 2 Device Recall Approach CTO Micro Wire Guide

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 Class 2 Device Recall Approach CTO Micro Wire Guidesee related information
Date Initiated by FirmOctober 14, 2024
Date PostedNovember 21, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0499-2025
Recall Event ID 95582
510(K)NumberK171897 
Product Classification Wire, guide, catheter - Product Code DQX
ProductApproach CTO Micro Wire Guide, RPN CMW-14-190-25G, GPN G50789
Code Information UDI-DI: 00827002507890; Lot Numbers: NS15635381 NS15618280 NS15466311 NS15212224 NS14992020
Recalling Firm/
Manufacturer		 Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
812-339-2235
Manufacturer Reason
for Recall		Devices from the affected device lots have labels that state the incorrect expiration dates.
FDA Determined
Cause 2		Labeling Change Control
ActionAn "URGENT: MEDICAL DEVICE RECALL" notification letter dated 10/14/24 was sent to customers. Actions to be Taken by the Customer 1. 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 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. Action being Taken by Cook Medical Cook Medical is removing affected products from the market. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500.
Quantity in Commerce10 units
DistributionInternational Distribution to: Korea only
Total Product Life CycleTPLC 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) Database510(K)s with Product Code = DQX
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