Home / Recalls / Organ Recovery Systems, Inc. / Z-1437-2020

Z-1437-2020 Class II Terminated

Recalled by Organ Recovery Systems, Inc. — Itasca, IL

Recall Details

Product Type: Devices
Report Date: March 11, 2020
Initiation Date: January 30, 2020
Termination Date: September 30, 2021
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 2274

Product Description

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.

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.

Distribution Pattern

Distributed nationwide (32 states) and to Canada.

Code Information

LKT2000 Lots 119944, 119765, 119648, 120055, 120242.