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U.S. Department of Health and Human Services

Class 2 Device Recall LKT200 Perfusion Circuit for Lifeport Kidney Perfusion Transporter

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  Class 2 Device Recall LKT200 Perfusion Circuit for Lifeport Kidney Perfusion Transporter see related information
Date Initiated by Firm January 30, 2020
Create Date March 04, 2020
Recall Status1 Terminated 3 on September 30, 2021
Recall Number Z-1437-2020
Recall Event ID 84880
510(K)Number K021362  
Product Classification System, perfusion, kidney - Product Code KDN
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.
Code Information LKT2000 Lots 119944, 119765, 119648, 120055, 120242.
Recalling Firm/
Manufacturer		 Organ Recovery Systems, Inc.
1 Pierce Pl Ste 475W
Itasca IL 60143-2618
For Additional Information Contact Chris Hill
847-824-2600
Manufacturer 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.
FDA Determined
Cause 2		 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 in Commerce 2274
Distribution Distributed nationwide (32 states) and to Canada.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = KDN and Original Applicant = ORGAN RECOVERY SYSTEMS, INC.
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