Fresenius Liberty Select Cycler Recalled for Software Overfill Risk
Fresenius Medical Care is recalling Liberty Select Cyclers due to a software issue that may cause overfill, posing a risk of serious injury or death.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The source text explicitly states that the hazard 'may result in serious injury or death,' which aligns with the rubric criteria for a Severe (4) rating involving significant injury reports or potential for serious harm.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling 9,293 units of the Liberty Select Cycler (Software v.2.8.7, Material Number RTLR108343). The device is indicated for acute and chronic peritoneal dialysis and was distributed nationwide.
The recall was initiated because the firm identified a software issue related to the Patient Line Check (PLC). This issue may result in an increased risk of Overfill, also known as Increased Intraperitoneal Volume (IIPV). The source text states that Overfill/IIPV may result in serious injury or death.
Patients using the affected devices should contact their healthcare provider or the recalling firm for instructions on how to proceed. The specific serial numbers affected are listed in the official recall documentation.
The recalled product
- Product
- Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
- Affected units
- 9,293
Distribution
Distributed nationwide across the United States.
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