Fresenius Liberty Cycler Set Recalled for Leak and Contamination Risk
Fresenius Medical Care is recalling 5,590 Liberty Cycler Sets due to a small risk of leaks that could contaminate dialysate and cause 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 risk of harm (peritonitis) from a medical device defect where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 5,590 units of Fresenius Liberty Cycler Set Single Conn. Ext. DL. (Part Number: 050-87216). The affected units are from Lot 12BR08009 and were distributed nationwide. These sets are used for acute and chronic peritoneal dialysis.
The recall is being issued because there is a small risk of a leak in the Cycler Sets. If the set is punctured, the dialysate may become contaminated, which can potentially result in peritonitis.
Patients and healthcare providers should stop using the affected Cycler Sets and contact their healthcare provider or Fresenius Medical Care for further instructions.
The recalled product
- Product
- Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
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)
- Lot 12BR08009
Distribution
Distributed nationwide across the United States.
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