Organ Recovery Systems recalls LKT200 Perfusion Circuits (Lots 119944, 119765, 119648, 120055, 120242) due to potential leakage at sample port assembly that could cause loss of perfusion solution needed for kidney transport.
Observed leakage at the sample port assembly which could potentially lead to loss of perfusion solution needed to maintain continuous machine perfusion.
Organ Recovery Systems is recalling LKT200 Perfusion Circuits used in kidney transport systems because they may leak at the sample port, risking loss of perfusion solution needed to keep kidneys viable during transport. This could lead to kidney damage or failure if the solution is lost.
The circuit may leak at the sample port assembly, which could cause perfusion solution to be lost. This loss might disrupt the continuous machine perfusion needed to keep kidneys viable during transport, potentially leading to kidney damage or failure.
Kidney transplant recipients and their medical teams who use the LKT200 Perfusion Circuit with Lifeport Kidney Perfusion Transporter (KTR) systems are most at risk. The recall affects specific production lots of the circuit.
Check if you have the LKT200 Perfusion Circuit with Lifeport Kidney Perfusion Transporter (KTR) system. The affected lots are 119944, 119765, 119648, 120055, and 120242.
Identify if your LKT200 Perfusion Circuit has one of the affected lots: 119944, 119765, 119648, 120055, or 120242.
The circuit may leak at the sample port assembly, which could cause loss of perfusion solution needed to maintain kidney viability during transport.
Check if your LKT200 Perfusion Circuit has one of the affected lots (119944, 119765, 119648, 120055, 120242). If so, contact Organ Recovery Systems for instructions.
The recall record does not mention a remedy or fix.
We’ve drafted a message you can send Organ Recovery Systems to request your refund or repair — edit it as you like.
Subject: Recall Z-1437-2020 — Organ Recovery Systems Organ Recovery Systems Hello, I own a Organ Recovery Systems that is covered by recall Z-1437-2020 from Organ Recovery Systems. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
