Fresenius Recalls Liberty Cycler Cassettes Due to Potential Solution Leakage
Fresenius Medical Care is recalling Liberty Cycler Cassettes because damaged units may leak dialysis solution into the cycler, posing a contamination risk.
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 defect that poses a risk of contamination, but the source text does not report any illnesses or injuries, fitting the 'High' severity criteria for risk-of-harm products where injury has not yet been reported.
Plain-English summary
Fresenius Medical Care Renal Therapies Group, LLC is recalling Liberty Cycler Cassettes, which are disposable cassettes used to perform peritoneal dialysis in conjunction with the Liberty cycler. The recall covers approximately 33.7 million cassettes and 18,674 Liberty Cyclers distributed nationwide in the United States.
The recall is being conducted because a damaged cassette can cause peritoneal dialysis solution to leak into the cycler. This leakage is identified as a potential risk for contamination. The source text does not report any specific illnesses or injuries associated with this defect.
Patients using these devices should follow the additional instructions provided for step-by-step handling and inserting the cassette into the Liberty Cycler set to mitigate the risk.
The recalled product
- Product
- Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2)…
- Hazard
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 lots
Distribution
Distributed nationwide across the United States.
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Similar recalls
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