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U.S. Department of Health and Human Services

Class 2 Device Recall Fixed Core Wire Guide

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 Class 2 Device Recall Fixed Core Wire Guidesee related information
Date Initiated by FirmAugust 16, 2022
Date PostedSeptember 28, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1832-2022
Recall Event ID 90793
510(K)NumberK171764 
Product Classification Wire, guide, catheter - Product Code DQX
ProductFixed Core Wire Guide, Guidewire Reference Part Number/GPN THSCF-25-180-3 G02165 TSCF-25-80-3 G00476
Code Information THSCF-25-180-3 G02165 UDI-DI: 00827002021655 Lots/Expiration Dates: 14797761 16-06-2027 14813704 27-06-2027 TSCF-25-80-3 G00476 UDI-DI: 00827002004764 Lots/Expiration Dates: NS14797766 16-06-2027 NS14807600 22-06-2027 NS14821727 30-06-2027
Recalling Firm/
Manufacturer		 Cook Incorporated
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
800-457-4500
Manufacturer Reason
for Recall		Cook Medical identified that devices from the affected device lots may have a complete breach of the chevron seal of the packaging. Therefore, the sterility of affected devices may be compromised.
FDA Determined
Cause 2		Under Investigation by firm
ActionOn August 16, 2022, Cook Medical notified affected customers of the recall. Customers were instructed to immediately cease all further distribution and use of the affected products. Affected product should be quarantined and returned to Cook Medical to receive product credit. If you have any questions or concerns, please contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235
Quantity in Commerce58 US; 5 OUS
DistributionDomestic distribution nationwide. Foreign distribution worldwide.
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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