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Organ Recovery Systems, Inc. recalls LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory
Recalled March 11, 2020 · FDA recall Z-1437-2020 · Organ Recovery Systems
Hazard
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion. · FDA Class II
Units
2274
Sold at
Distributed nationwide (32 states) and to Canada.
Description
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
Product
LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The 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.
Manufacturer(s)
Organ Recovery Systems, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →