FDA-Device2020-03-11Class II
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.
Organ Recovery Systems, Inc.
Hazard
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
Sold states
Distributed nationwide (32 states) and to Canada.
Affected count
2274
Manufactured in
1 Pierce Pl Ste 475W, N/A, Itasca, IL, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1437-2020Don't want to check this manually?
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