Device recall
Z-1437-2020: LKT200 Perfusion Circuit, part of Lifeport Kidney Perfusion Transporter KTR…
FDA device recall · Class II · Organ Recovery Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1437-2020 |
|---|---|
| Recall event | 84880 |
| 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… |
| Product code | KDN |
| Recalling firm | Organ Recovery Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 30, 2021 |
| 510(k) numbers | K021362 |
| FEI number | 3004068499 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database