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Recall Observatory FDA recall evidence

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

Z-0960-2021

January 04, 2021

Class II

Product summary

Firm
Cook Inc.
Event
Event 87087
Status
Terminated
Classification
Class II
Quantity
42 units
Official record key
device-enforcement:Z-0960-2021

Official wording

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

Code information: Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897

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

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

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