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U.S. Department of Health and Human Services

Class 2 Device Recall SofFlex MultiLenqth Ureteral Stent Set

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 Class 2 Device Recall SofFlex MultiLenqth Ureteral Stent Setsee related information
Date Initiated by FirmJanuary 04, 2019
Create DateFebruary 04, 2020
Recall Status1 Terminated 3 on May 29, 2020
Recall NumberZ-0976-2020
Recall Event ID 82026
Product Classification Stent, ureteral - Product Code FAD
ProductSof-Flex Multi-Lenqth Ureteral Stent Set, Global Product No. G14773 G15000 G14867 G14951 G17852
Code Information 8011038 NS7998389 NS8008388 NS8018651 NS8030247 NS8037667 7990842 8599605 8625597 8625598 8172131 8172132 8193001 
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.
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