FDA Medical Device Recalls (openFDA)
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.
- Recall number
- Z-1437-2020
- Recalling firm
- Organ Recovery Systems, Inc.
- 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 kidneys for the preservation, transportation and eventual transplantation into a recipient.
- Status
- Terminated
- Initiated
- 2020-01-30
- Posted
- not on file
- Terminated
- 2021-09-30
- 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.
- Lot, serial or model codes
- LKT2000 Lots 119944, 119765, 119648, 120055, 120242.
- 510(k) numbers
- ["K021362"]
- PMA numbers
- not on file
- Product code
- KDN
- Firm FEI
- 3004068499
- Firm city
- Itasca
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28