FDA-Device2020-02-12Class II
Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
Cook Inc.
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.
Sold states
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.
Affected count
13388 total
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Bander Ureteral Diversion Open-End Stent Set, Global Product No. G14822 G14823
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0972-2020Don't want to check this manually?
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