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U.S. Department of Health and Human Services

Class 2 Device Recall Double Flexible Tipped Wire Guide

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 Class 2 Device Recall Double Flexible Tipped Wire Guidesee related information
Date Initiated by FirmAugust 16, 2022
Date PostedSeptember 28, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1831-2022
Recall Event ID 90793
510(K)NumberK171912 K181351 
Product Classification Wire, guide, catheter - Product Code DQX
ProductDouble Flexible Tipped Wire Guide, Guidewire Reference Part Number/GPN TDOC-35-145-0-3 G00362 C-TDOC-18-50-0-2 G05146 TDOC-35-50-0-3 G00364 C-DOC-21-40-0-2 G02431 C-TDOC-21-50-0-2 G05195 C-TDOC-25-50-0-2 G05145
Code Information TDOC-35-145-0-3 G00362 UDI-DI: 00827002003620 Lots/Expiration Date: 14793053 14-06-2027 14797769 16-06-2027 14802346 20-06-2027 14802348 20-06-2027 14812034 24-06-2027 C-TDOC-18-50-0-2 G05146 UDI-DI: 00827002051461 Lots/Expiration Date: 14795065 15-06-2027 TDOC-35-50-0-3 G00364 UDI-DI: 00827002003644 Lots/Expiration Date: 14802347 20-06-2027 C-DOC-21-40-0-2 G02431 UDI-DI: 00827002024311 Lots/Expiration Date: NS14795068 15-06-2027 C-TDOC-21-50-0-2 G05195 UDI-DI:00827002051959 Lots/Expiration Date: NS14802356 20-06-2027 C-TDOC-25-50-0-2 G05145 UDI-DI: 00827002051454 Lots/Expiration Date: NS14818384 29-06-2027 NS14818387 29-06-2027
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 Commerce150 US, 97 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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