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U.S. Department of Health and Human Services

Class 2 Device Recall Coons Interventional Wire Guide

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  Class 2 Device Recall Coons Interventional Wire Guide see related information
Date Initiated by Firm August 16, 2022
Date Posted September 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-1828-2022
Recall Event ID 90793
510(K)Number K171764  
Product Classification Wire, guide, catheter - Product Code DQX
Product Coons Interventional Wire Guide, Guidewire;
Reference Part Number/GPN:
THSF-35-145-COONS G02356
THSF-38-145-COONS G02324
THSF-35-180-COONS G02621
THSF-35-80-COONS G12268
Code Information THSF-35-145-COONS G02356 UDI-DI 00827002023567 Lot/Expiration Date 14757818 27-05-2027 14795059 15-06-2027 14797781 16-06-2027 14802363 20-06-2027 THSF-38-145-COONS G02324 UDI-DI 00827002023246 Lot/Expiration Date 14793057 14-06-2027 THSF-35-180-COONS G02621 UDI-DI 00827002026216 Lot/Expiration Date 14797773 16-06-2027 THSF-35-80-COONS G12268
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		 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
Action On 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 Commerce 1,236 US
Distribution Domestic distribution nationwide. Foreign distribution worldwide.
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 Incorporated
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