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Cook Inc. recalls Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875
Recalled February 12, 2020 · FDA recall Z-0977-2020 · Cook
Hazard
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 Class II
Units
13388 total
Sold at
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.
Description
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.
Product
Universa Firm Ureteral Stent, Global Product No. G49864 G49865 G49866 G49867 G49868 G49869 G49870 G49874 G49875 G49877 G49879 G49881 G49882 G49887 G49888
Manufacturer(s)
Cook Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →