Reported Feb 17, 2021 · Terminated

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

Cook Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Cook Inc. · 750 N Daniels Way · Bloomington, IN · 47404-9120

Is this the product you have?

  • 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
  • GPNG14837
Lot codes and dates
  • Lot Numbers13024536 13089895
  • NS13089897 UDI(01)00827002148376(17)230303(10)13024536 (01)00827002148376(17)230327(10)13089895 (01)00827002148376(17)230327(10)NS13089897
Amount recalled
42 units

Where it was sold

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 16, 2021 · Data as of Sep 19, 5:45 PM UTC

RecallNow is not a government agency. Every fact on this page is published by the FDA, USDA or CPSC and links back to their notice.