Recall Z-1437-2020— Organ Recovery Systems, Inc.
Class II · Terminated
Class II FDA medical device recall by Organ Recovery Systems, Inc., initiated 2020-01-30, terminated 2021-09-30. It names one FDA 510(k) clearance: K021362. 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.. Reason: Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion..
- Recalling firm
- Organ Recovery Systems, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2020-01-30
- Terminated
- 2021-09-30
- Firm location
- Itasca, IL, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.