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U.S. Department of Health and Human Services

Class 2 Device Recall Percutaneous Entry Set

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  Class 2 Device Recall Percutaneous Entry Set 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-0967-2020
Recall Event ID 82026
510(K)Number K833762  
Product Classification Catheter, nephrostomy - Product Code LJE
Product Percutaneous Entry Set, Nephrostomy Catheter, Global Product No. G14649
Code Information 8109245 NS8109246 
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 = LJE and Original Applicant = VPI
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