Reported Mar 11, 2020 · Terminated

LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an…

Organ Recovery Systems, 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: Organ Recovery Systems, Inc. · 1 Pierce Pl Ste 475W · Itasca, IL · 60143-2618

Is this the product you have?

  • LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion
  • Transporter KTR - Product UsageThe circuit is an accessory to LifePort Kidney Perfusion Transporter (KTR) Isolated kidney perfusion and transport system, which is intended to be used for the continuous hypothermic machine perfusion of kidneys for the preservation, transportation and eventual transplantation into a recipient
Lot codes and dates
    • LKT2000 Lots 119944
    • 119765
    • 119648
    • 120055
    • 120242
Amount recalled
2274

Where it was sold

  • Nationwide

Why it was recalled

Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.

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 30, 2021 · Data as of Sep 19, 5:36 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.