Fresenius Liberty Cycler Recalled for Fluid Leak and Contamination Risk
Fresenius Medical Care is recalling Liberty Cyclers because fluid leaks may contaminate dialysate, potentially causing peritonitis.
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 involves a medical device where a defect (fluid leak) poses a risk of harm (peritonitis) but the source text does not report any confirmed illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products without reported injury.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling the Fresenius Liberty Cycler, a portable device used for acute and chronic peritoneal dialysis. The recall involves 16,600 units distributed nationwide in the United States.
The recall is being issued because fluid leaking may be observed inside the pump compartment of the device. This leakage may result in the dialysate becoming contaminated, which could potentially cause peritonitis in patients using the device.
Consumers should contact Fresenius Medical Care for instructions on how to address the issue. The source text does not specify a particular action such as stopping use immediately, but users should follow the manufacturer's guidance regarding the fluid leak.
The recalled product
- Product
- Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Affected units
- 16,600
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 serial numbers
Distribution
Distributed nationwide across the United States.
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