FDA Recall
Terminated
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.
Recall: Z-1437-2020
·
Initiated January 30, 2020
Recall
- Recall Number
- Z-1437-2020
- Event Number
- 84880
- Firm
- Organ Recovery Systems, Inc.
- FEI Number
- 3004068499
- Product Code
- KDN
- Status
- Terminated
- Root Cause
- Reprocessing Controls
- Initiated
- January 30, 2020
- Terminated
- September 30, 2021
- Address
- 1 Pierce Pl, Ste 475W, Itasca, IL, 60143-2618
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
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
Action
Letters were sent 01/30/2020 to all customers advising cease usage and quarantine all LKT200 units and return to firm.
Distribution
Distributed nationwide (32 states) and to Canada.
Quantity
2274