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U.S. Department of Health and Human Services

Class 2 Device Recall Universa Firm Ureteral Stent

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 Class 2 Device Recall Universa Firm Ureteral Stentsee related information
Date Initiated by FirmJanuary 04, 2019
Create DateFebruary 04, 2020
Recall Status1 Terminated 3 on May 29, 2020
Recall NumberZ-0977-2020
Recall Event ID 82026
510(K)NumberK961446 
Product Classification Stent, ureteral - Product Code FAD
ProductUniversa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
Code Information 7953153 8077981 8070702 NS8176831 7999744 7999746 8077986 8077988 8172070 8176832 8176833 8176834 NS7999747 NS8180869 7990863 8424316 8424317 8424318 NS7990867 7988039 7998403 7998404 8001365 8040131 8193749 8197930 8197931 8412989 8412990 8424332 7988039X 8003098 8506037 NS8018667 8594594 8197932 8594595 NS8197934 NS8417599 NS8417600 NS7998407 NS8033592 NS8033593 
FEI Number 1820334
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information ContactCook Medical Customer Relations Department
800-457-4500
Manufacturer Reason
for Recall		The wire guide may be incorrectly loaded into the wire guide holder, leading to the stiff tip of the wire guide being introduced into the patient instead of the flexible tip.
FDA Determined
Cause 2		Process control
ActionOn January 4, 2019, the firm distributed Urgent Medical Device Recall letters to customers via courier mail. Customers were informed that affected lots may contain a wire guide that was incorrectly loaded into the wire guide holder.
Quantity in Commerce13388 total
DistributionDomestic distribution to nationwide US. Foreign distribution to Australia, Belgium, Bolivia, Canada, Canary Islands, Chile, China, Colombia, Croatia, Czech Republic, Denmark, France, French Polynesia, Germany, Guatemala, Honduras, Hungary, India, Ireland, Italy, Japan, Korea, Luxembourg, Malaysia, Malta, Mexico, Mongolia, Netherlands, New Caledonia, New Zealand, Oman, Panama, Paraguay, Poland, Puerto Rico, Romania, Russian Federation, South Africa, Spain, Sweden, Switzerland, Taiwan, Trinidad and Tobago, United Arab Emirates, and the United Kingdom.
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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FAD
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