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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 08, 2024
Date PostedNovember 08, 2024
Recall Status1 Open3, Classified
Recall NumberZ-0346-2025
Recall Event ID 95528
510(K)NumberK171897 
Product Classification Wire, guide, catheter - Product Code DQX
ProductApproach CTO Micro Wire Guide, Guide Wire, Catalog Prefix CMW; Reference Part Numbers: CMW-14-190-12G CMW-14-190-18G CMW-14-190-25G CMW-14-190-6G CMW-14-300-12G CMW-14-300-18G CMW-14-300-25G CMW-14-300-6G
Code Information RPN /UDI-DI/ Lots: CMW-14-190-12G/ 00827002507876/ 15763571 15773059 15783003 15885574 NS15821244 NS15849650 CMW-14-190-18G/ 00827002507883/ 15763579 15769462 15802931 15811662 15898546 15925115 15943888 15974443 15802931X NS15849651 CMW-14-190-25G/ 00827002507890/ 15778254 15791923 15802932 15849652 15891914 15891915 15995205 CMW-14-190-6G/ 00827002507869/ 15800162 15907477 16018911 CMW-14-300-12G/ 00827002507913/ 15718982 15763552 15763561 15763577 15763604 15763605 15794897 15802924 15858395 15858399 15885578 15891916 15898543 15915909 15943896 15945778 15952518 15956556 15958706 NS15843567 NS15892396 CMW-14-300-18G/ 00827002507920/ 15718980 15763553 15763563 15763585 15765959 15794895 15802926 15802933 15835853 15858397 15863270 15891906 15891910 15892397 15900750 15913326 15915903 15915904 15945777 15945781 15958704 15971786 NS15773060 NS15811659 NS15898544 NS15898545 NS15945782 CMW-14-300-25G/ 00827002507937/ 15718981 15731211 15763580 15763591 15763609 15765960 15794896 15800156 15811660 15835856 15863271 15885579 15891911 15892398 15915902 15943887 15943891 15943892 15943897 16018907 NS15821243 NS15945783 NS15974440 NS16006214 NS16025239 CMW-14-300-6G/ 00827002507906/ 15763597 15778251 15794898 15858400 15891908 15907474 15925117 15995202 NS15800160 NS15829388 NS15849653 NS16008457
FEI Number 1820334
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		Affected device lots have labels that state the incorrect expiration dates.
FDA Determined
Cause 2		Labeling Change Control
ActionOn October 8, 2024, the firm notified affected consignees through Urgent Medical Device Recall letters. Customers were informed of the product issue and instructed to quarantine any affected product that remains unused. Product should be returned to Cook Medical. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
Quantity in Commerce2,005 US; 1,145 OUS
DistributionWorldwide - US Nationwide distribution.
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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