Fresenius Liberty Cycler Set Recalled for Potential Leakage During Dialysis
Fresenius Medical Care is recalling 5,480 units of the Liberty Cycler Set due to a risk of cassette leakage during setup or treatment.
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 harm (leakage) in a medical device where injury has not yet been reported, fitting the 'High' severity criteria.
Plain-English summary
Fresenius Medical Care Holdings, Inc. is recalling 5,480 units of the Fresenius Liberty Cycler Set Single Conn./Ext DL (Product Number: 050-87216). The affected units are identified by Lot 11PR08083 and were distributed nationwide. This product is an Automated Peritoneal Dialysis System featuring an integrated stay safe patient connector and an extended drain line.
The recall was initiated because the cassette may leak during the setup process or during peritoneal dialysis treatment. The U.S. Food and Drug Administration has classified this as a Class II recall.
Patients using this specific lot of the dialysis system should stop using the product and contact their healthcare provider or the manufacturer for instructions on replacement or further action.
The recalled product
- Product
- Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Hazard
- Affected units
- 5,480
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 11PR08083
Distribution
Distributed nationwide across the United States.
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