Recall Z-1437-2020 ยท KDN System, Perfusion, Kidney
Organ Recovery Systems, Inc.
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.
| Date | Jan 30, 2020 |
| Status | Terminated |
| Reason | Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion. |
| Root cause | Reprocessing Controls |
| Action | Letters were sent 01/30/2020 to all customers advising cease usage and quarantine all LKT200 units and return to firm. |
| Quantity | 2274 |
| Distribution | Distributed nationwide (32 states) and to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K021362 | LIFEPORT, KIDNEY PERFUSION TRANSPORTER (KTR) Organ Recovery Systems, Inc., Jul 31, 2003 |