FDA recall Z-0960-2021

Cook Inc. · Class II · device

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

Reason for recall

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

Distribution

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

Key facts

Status: Terminated
Initiation date: 2021-01-04
Report date: 2021-02-17
Termination date: 2021-09-16
Voluntary/Mandated: Voluntary: Firm initiated
Location: Bloomington, IN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0960-2021