Fresenius Liberty Cycler Peritoneal Dialysis Machines Recalled for Door Latch Defect
Fresenius Medical Care is recalling 14,094 Liberty Cycler peritoneal dialysis machines because the door latch may not fully close, posing a risk of injury or treatment delay.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II and involves a risk of physical injury and treatment delay, but the source text does not report any actual injuries or illnesses, fitting the criteria for a High severity score.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 14,094 units of the Fresenius Liberty Cycler-Peritoneal Dialysis Cycler, Models 180111 and RTLR180111. The recall covers all lot numbers and includes units distributed nationwide.
The recall is being issued because the door latch on the machines may not fully close, which could cause the door to open unexpectedly. If the door opens, it may make physical contact with objects or the patient near the machine. This defect may cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV), also known as overfill.
Patients and healthcare providers using these specific models should contact Fresenius Medical Care for instructions on how to address the defect. The source text does not specify a particular action such as stopping use immediately, but users should follow the manufacturer's guidance regarding the door latch issue.
The recalled product
- Product
- Fresenius Liberty Cycler-Peritoneal Dialysis Cycler Model: 180111 and RTLR180111
- Affected units
- 14,094
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 (1)
- All lot numbers
Distribution
Distributed nationwide across the United States.
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