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U.S. Department of Health and Human Services

Class 2 Device Recall Cope Mandril Wire Guide

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 Class 2 Device Recall Cope Mandril Wire Guidesee related information
Date Initiated by FirmAugust 16, 2022
Date PostedSeptember 28, 2022
Recall Status1 Open3, Classified
Recall NumberZ-1830-2022
Recall Event ID 90793
510(K)NumberK171997 
Product Classification Wire, guide, catheter - Product Code DQX
ProductCope Mandril Wire Guide (Stainless Steel), Stainless Steel Guidewire Reference Part Number/GPN PMG-18SP-60-COPE G05183 PMG-18SP-100-COPE G05822 PMG-18SP-125-COPE G10077
Code Information PMG-18SP-60-COPE G05183 UDI-DI: 00827002051836 Lot/Expiration Date 14795012 15-06-2027 14801636 20-06-2027 14804264 21-06-2027 14804265 21-06-2027 14806984 22-06-2027 14806985 22-06-2027 14815841 27-06-2027 14815842 27-06-2027 14815852 27-06-2027 14815853 27-06-2027 14815854 27-06-2027 14819080 29-06-2027 14819081 29-06-2027 14831205 07-07-2027 14831206 07-07-2027 14841236 14-07-2027 PMG-18SP-100-COPE G05822 UDI-DI: 00827002058224 Lots/Expiration Dates 14797819 16-06-2027 PMG-18SP-125-COPE G10077 UDI-DI: 00827002100770 Lots/Expiration Dates 14809295 23-06-2027 14809296 23-06-2027
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 Commerce2,748 US; 302 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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