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Recall Observatory FDA recall evidence

Device 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.

Z-1437-2020

January 30, 2020

Class II

Product summary

Firm
Organ Recovery Systems, Inc.
Event
Event 84880
Status
Terminated
Classification
Class II
Quantity
2274
Official record key
device-enforcement:Z-1437-2020

Official wording

Reason: Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.

Code information: LKT2000 Lots 119944, 119765, 119648, 120055, 120242.

Distribution pattern: Distributed nationwide (32 states) and to Canada.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.