Liberty®
Liberty Cycler Set, One patient connector with extended patient and drain lines
1manufacturer
5catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Viant Medical Suzhou EPZ Co., Ltd. | Jiangsu | Jiangsu | Contract manufacturer | 3 |
Record
| Listed by | Fresenius Medical Care, United States |
|---|---|
| FDA product code | FKX |
| Device type | System, Peritoneal, Automatic Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5630 |
| 510(k) | K811986 |
| Record published | 2015-10-02 |
| Record revised | 2023-06-02 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 10, case of 30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 026-20226 | In distribution | |
| 050-87216 | In distribution | |
| 026-20036A | In distribution | |
| 050-87215 | In distribution | |
| 050-87212 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sharesource Connectivity Platform | Baxter Healthcare Corporation | 7 |
| Peritoneal Dialysis | Merit Medical Systems, Inc. | 6 |
| VersiPD | Fresenius Medical Care | 4 |
| VersiPD | Fresenius USA, Inc. | 3 |
| Liberty® PDx | Fresenius Medical Care | 3 |
| Liberty | Fresenius Medical Care Renal Therapies Group, LLC | 2 |
| Premier | Fresenius Medical Care | 2 |
| Safe-Lock® | Fresenius Medical Care | 2 |
| HomeChoice APD System | Baxter Healthcare Corporation | 2 |
| LOW Recirculation Volume APD SET | Baxter Healthcare Corporation | 2 |
| Sharesource | Baxter Healthcare Corporation | 2 |
| HomeChoice PRO APD System | Baxter Healthcare Corporation | 2 |
Showing 12 of 38. All products under System, Peritoneal, Automatic Delivery
Recalls Naming This Product
10 recalls name this product by its own identifiers, the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|---|---|
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2021-04-28 | Class II | Environmental control | Exposed to freezing temperatures due to refrigerated truck malfunctions | 6 Cases | 2022-08-08 |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2019-05-29 | Class II | Use error | 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. | 33732973 Cassettes; 18,674 Liberty Cyclers | 2020-11-19 |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2015-12-15 | Class II | Device Design | The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitonea | 14,094 units | 2019-10-07 |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2013-10-14 | Class II | Device Design | Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis | 16,600 | 2021-05-18 |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2013-06-03 | Class II | Unknown/Undetermined by firm | Cassette may leak during set up or during peritoneal dialysis treatment | 5480 units | 2014-06-18 |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2012-10-12 | Class II | Process control | There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis. | 560 cases, totaling 5590 units | 2020-12-30 |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2012-03-30 | Not classified | Software design | Increased risk of intraperitoneal volume (IIPV), referred to as Overfill | 10,146 units | 2016-08-04 |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2010-09-03 | Not classified | Nonconforming Material/Component | Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis. | 363,265 units | 2023-02-16 |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2010-09-03 | Not classified | Nonconforming Material/Component | Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis. | 1524 units | 2023-02-16 |
| Fresenius Medical Care Renal Therapies Group, LLC | 510(k) number | 2010-09-03 | Not classified | Nonconforming Material/Component | Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis. | 5799 units | 2023-02-16 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.