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 119944119765119648120055120242
- 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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