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U.S. Department of Health and Human Services

Class 2 Device Recall Universa Soft Ureteral Stent

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  Class 2 Device Recall Universa Soft Ureteral Stent see related information
Date Initiated by Firm January 04, 2019
Create Date February 04, 2020
Recall Status1 Terminated 3 on May 29, 2020
Recall Number Z-0978-2020
Recall Event ID 82026
510(K)Number K151051  
Product Classification Stent, ureteral - Product Code FAD
Product Universa Soft Ureteral Stent, Global Product No. G49887
G49933
G49934
G49937
G49940
G49941
G49942
G49945
G49947
G49948
G49949
G49950
G49951
G49953
G49955
G49956
G49957
G49958
G49959
G49961
G53145
G53676
G53677
G53687
G53689
G53692
G53693
G53694
G53703
G53706
G53711
G53723
G53724
G53725
G53726
Code Information 8078013 8172113 8001369 8183381 NS7994828 8147249 8417607 8600625 NS8417608 NS7990886 7990888 8594598 8594599 8056338 8018675 8056337 8629502 NS8018677 NS8053511 NS8417612 NS8011064 NS8417614 NS8417615 7998415 8147267 8187145 8008415 8011065 8078026 8008416 8078027 8078028 8150465 8180873 8008417 8033600 8427840 8427841 8507952 8507953 8507954 8507955 7990900 8003104 NS7990899 7998422 7998423 8047039 8056331 8066970 8066972 8066973 8066974 8147295 8147296 8421552 8427843 8427847 8594610 7994831 8008426 8056327 8066976 8066977 8207795 8629522 NS8026827 NS8030272 NS8421563 NS8421564 NS8421566 NS8421567 8599661 8421568 NS8599665 NS8060481 NS8033606 NS8629506 NS8629507 NS8008428 NS8421571 NS8421572 NS8599666 NS8599667 NS8147321 NS8421573 NS8008429 
Recalling Firm/
Manufacturer		 Cook Inc.
750 N Daniels Way
Bloomington IN 47404-9120
For Additional Information Contact Cook 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
Action On 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 Commerce 13388 total
Distribution Domestic 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 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FAD and Original Applicant = COOK INCORPORATED
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