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Cook Inc. Recall 87087

Description: 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. Recall 87087 Information

StatusTerminated
Mandated?Voluntary: Firm initiated
Recall NumberZ-0960-2021
Event ID87087
Event DescriptionCook 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
Product TypeDevices
DistributionFL, KY, MD, NS, NY, PA, TX Foreign: Canada, Switzerland
Quantity42 units
Recall ReasonManufactured with incorrect material, which may result in the stent being stiffer and potentially susceptible to degradation could potentially lead to breakage/fragmentation.
Device Classification20210217
Device Code InfoLot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897
Center Classification Date20210205
Recall Initiation Date20210104
Recalling FirmCook Inc.
Initial Notification Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
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