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.
Reported: March 11, 2020 Initiated: January 30, 2020 #Z-1437-2020
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.
Details
- Recalling Firm
- Organ Recovery Systems, Inc.
- Units Affected
- 2274
- Distribution
- Distributed nationwide (32 states) and to Canada.
- Location
- Itasca, IL
Frequently Asked Questions
What product 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.. Recalled by Organ Recovery Systems, Inc.. Units affected: 2274.
Why was this product recalled? ▼
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on March 11, 2020. Severity: Moderate. Recall number: Z-1437-2020.
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