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.
FDA Recall Z-1437-2020 · Posted None
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Recalling FirmOrgan Recovery Systems, Inc.
Recall StatusTerminated
Product CodeKDN
Date Initiated2020-01-30
Date Terminated2021-09-30
Product Quantity2274
Reason for Recall
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
Firm Action
Letters were sent 01/30/2020 to all customers advising cease usage and quarantine all LKT200 units and return to firm.
Root Cause
Reprocessing Controls
Distribution Pattern
Distributed nationwide (32 states) and to Canada.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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