FDA-Device2021-02-17Class II
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
Cook Inc.
Hazard
Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Sold states
FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland
Affected count
42 units
Manufactured in
750 N Daniels Way, N/A, Bloomington, IN, United States
Products
Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) and leaving an indwelling ureteral stent Reference Part Number (RPN): 003700 GPN: G14837
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0960-2021Don't want to check this manually?
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