Cook Inc.: 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 s

Is my product affected?

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

• UPC 00827002148376

Check against the official notice below — it lists the full affected range.

What happened

Cook Inc. is recalling 42 units of the Cook Medical Kwart Retro-Inject Ureteral Stent Set 7.0Fr. 22-32cm due to a manufacturing defect. The stents were made with incorrect material, which makes them stiffer than intended and prone to degradation. This defect could potentially cause the stent to break apart or fragment inside the patient's body. The affected stents were distributed in Florida, Kentucky, Maryland, New York, Pennsylvania, Texas, and the Canadian provinces, with specific lot numbers identified.

The recalled lot numbers are 13024536, 13089895, and NS13089897. The product is used during a urological procedure called Extracorporeal Shock Wave Lithotripsy (E.S.W.L.) to help manage kidney stones. The source document does not specify what action affected consumers should take in response to this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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

Details from the source

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 Quantity: 42 units Lot/code info: Lot Numbers: 13024536 13089895 NS13089897 UDI: (01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897

Source

Official record: FDA (Device enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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