Cook Inc. recalls Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm -Used for retrograde injection during Extracorporeal…

Recall date

January 4, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0960-2021

FDA classification

Class II

Brand / firm

Cook Inc.

Sold / distributed

FL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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