Z-1437-2020Class II

LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR -

Name: Z-1437-2020 LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR -
Creator: Organ Recovery Systems, Inc.
Published: 2020-01-30
License: https://open.fda.gov/license/

Organ Recovery Systems, Inc. / initiated 2020-01-30 / Terminated

FDA source

Organ Recovery Systems, Inc. began a recall of LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessory to LifePort Kidney Perfusion... on 2020-01-30. FDA classified it as Class II and gives the reason as "Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1437-2020
Classification: Class II
Status: Terminated
Initiated: 2020-01-30
Posted: 2020-03-04
Terminated: 2021-09-30
Recalling firm: Organ Recovery Systems, Inc.
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.
Product code: KDN System, Perfusion, Kidney
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.
FDA root cause: Reprocessing Controls
Action: Letters were sent 01/30/2020 to all customers advising cease usage and quarantine all LKT200 units and return to firm.
Quantity in commerce: 2274
Distribution: Distributed nationwide (32 states) and to Canada.
Product codes and lots: LKT2000 Lots 119944, 119765, 119648, 120055, 120242.

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1437-2020
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1437-2020	Class II	Terminated	Voluntary: Firm initiated	2020-03-11	2020-03-04

Product code KDN

K021362Class IILifeport, Kidney Perfusion Transporter (Ktr)Organ Recovery Systems, Inc. / cleared 2003-07-31

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)