FDAJanuary 4, 2021device

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 recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Terminated

Brands named

cook

UPCs

00827002148376

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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