# FDA recall Z-1437-2020

> **Organ Recovery Systems, Inc.** · Class II · device recall initiated 2020-01-30.

## 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

- **Recall number:** Z-1437-2020
- **Recalling firm:** Organ Recovery Systems, Inc.
- **Classification:** Class II
- **Product type:** device
- **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

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

## Citation

> AI Analytics. FDA recall Z-1437-2020. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/Z-1437-2020. Source: US FDA. Licensed CC0.

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