medical Class II Updated 2021-02-17

Cook Inc. recalls Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22

Recalled Product

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


Hazard / Issue

Manufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.

Issued by

FDA

Affected States: FL, KY, MD, NY, PA, TX
Lot/Code Info: Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897
View official government recall

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