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U.S. Department of Health and Human Services

Class 2 Device Recall TorqFlex Wire Guide Australian Modification

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  Class 2 Device Recall TorqFlex Wire Guide Australian Modification see related information
Date Initiated by Firm August 16, 2022
Date Posted September 28, 2022
Recall Status1 Open3, Classified
Recall Number Z-1843-2022
Recall Event ID 90793
510(K)Number K171997  
Product Classification Wire, guide, catheter - Product Code DQX
Product Torq-Flex Wire Guide Australian Modification, Guidewire
Reference Part Number/GPN
STF-18-40-AUST G07304
Code Information STF-18-40-AUST G07304 UDI-DI: 00827002073043 Lots/Expiration Date: 14788615 13-06-2027 14816230 28-06-2027 14836977 12-07-2027
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 149 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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