FDA recall Z-1437-2020

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.

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

Distributed nationwide (32 states) and to Canada.

Key facts

Status

Terminated

Initiation date

2020-01-30

Report date

2020-03-11

Termination date

2021-09-30

Voluntary/Mandated

Voluntary: Firm initiated

Location

Itasca, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1437-2020