Organ Recovery Systems, Inc. recalls LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR - Product Usage: The circuit is an accessor…

Recall date

January 30, 2020

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1437-2020

FDA classification

Class II

Brand / firm

Organ Recovery Systems, Inc.

Sold / distributed

Distributed nationwide (32 states) and to Canada.

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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.