Food, drugs, devices › Fresenius Medical Care Renal Therapies Group, LLC
Device recall: Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conj
FDA enforcement event 83164 is a device recall by Fresenius Medical Care Renal Therapies Group, LLC of Waltham, MA, initiated 29 May 2019 and classified Class II, with 1 product record.
FDA defines Class II as 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. 88% of the 968 device enforcement events initiated in 2019 carry the same class.
Status: Terminated, terminated 19 Nov 2020. Initiation: voluntary: firm initiated. Fresenius Medical Care Renal Therapies Group, LLC has 22 enforcement events on this register, with a median of 1 product record per event.
Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.
Recalling firm
Fresenius Medical Care Renal Therapies Group, LLC, Waltham, MA.
Reason for recall
"Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination."
Distribution
"US Nationwide Distribution"
Product records
| Recall number | Product | Quantity | Class | Status | Report date |
|---|---|---|---|---|---|
| Z-2151-2019 | 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) LIBERTY Line Cycler Set with Stay-safe… | 33732973 Cassettes; 18,674 Liberty Cyclers | Class II | Terminated | 14 Aug 2019 |
Context
Other enforcement events for Fresenius Medical Care Renal Therapies Group, LLC
All 22 events for Fresenius Medical Care Renal Therapies Group, LLC
Questions and answers
Why was this device recalled?
FDA's record gives the reason for recall as: "Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination."
What does Class II mean?
FDA classifies recalls by relative degree of health hazard. 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.
Where was the product distributed?
FDA's distribution pattern field reads: "US Nationwide Distribution"
Is the recall still ongoing?
FDA lists the status as Terminated; the termination date is 19 Nov 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.
Where does this data come from?
openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.
Provenance
Source: openFDA device enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.