FDA Recalls LKT200 Perfusion Circuits Due to Leakage Risk
Organ Recovery Systems is recalling 2,274 LKT200 Perfusion Circuits because leakage at the sample port could cause loss of perfusion solution needed for kidney preservation.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls with potential for significant harm or hospitalization reports are rated as Severe (4). The loss of perfusion solution poses a significant risk to the viability of the organ intended for transplantation.
Plain-English summary
The U.S. Food and Drug Administration (FDA) has issued a Class II recall for the LKT200 Perfusion Circuit, manufactured by Organ Recovery Systems, Inc. The circuit is an accessory to the LifePort Kidney Perfusion Transporter (KTR) system, which is used for the continuous hypothermic machine perfusion of kidneys for preservation, transportation, and eventual transplantation.
The recall was initiated due to observed leakage at the sample port assembly. This defect could potentially lead to the loss of perfusion solution, which is necessary to maintain continuous machine perfusion of the kidneys. The recall covers 2,274 units distributed nationwide to 32 states and to Canada. The affected lots are LKT2000 Lots 119944, 119765, 119648, 120055, and 120242.
Healthcare facilities and users of the LifePort Kidney Perfusion Transporter system should check their inventory for the affected lot numbers. If the product is found, it should be removed from service and returned to the manufacturer or disposed of according to the recall instructions provided by Organ Recovery Systems, Inc.
The recalled product
- 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 mach
- Manufacturer
- Organ Recovery Systems, Inc.
- Hazard
- Affected units
- 2,274
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- LKT2000 Lots 119944
- 119765
- 119648
- 120055
- 120242.
Distribution
Distributed nationwide across the United States.
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