Itasca, IL, United States
Organ Recovery Systems, Inc. recalls
1 recall recorded since 2018, most recently on 30 January 2020. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Medical devices
- Recall started
- 30 January 2020
- Terminated
- 30 September 2021
- Reason
- 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.
- Initiated
- Voluntary: Firm initiated
- Recall number
- Z-1437-2020
- 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, whic
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.