Liberty
Liberty Cycler Set, single stay•safe® PIN patient connector, 10-foot patient line, 30-inch drain line
1manufacturer
2catalogue numbers in this listing
6510(k) clearances naming this product code
14recalls on this code
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 Renal Therapies Group, LLC, United States |
|---|---|
| FDA product code | FKX |
| Device type | System, Peritoneal, Automatic Delivery |
| Device class | Class 2 |
| Regulation | 21 CFR 876.5630 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K173718 |
| Record published | 2024-03-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Case of 14 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 050-87215A | In distribution | |
| 050-87216A | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sharesource Connectivity Platform | Baxter Healthcare Corporation | 7 |
| Peritoneal Dialysis | Merit Medical Systems, Inc. | 6 |
| Liberty® | Fresenius Medical Care | 5 |
| VersiPD | Fresenius Medical Care | 4 |
| VersiPD | Fresenius USA, Inc. | 3 |
| Liberty® PDx | Fresenius Medical Care | 3 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K222318 | 2022-10-31 |
| K212522 | 2022-04-15 |
| K181108 | 2018-05-24 |
| K173718 | 2018-05-01 |
| K171652 | 2017-09-15 |
| K141145 | 2014-07-30 |
Recalls Naming This Product
1 recall names this product by its own identifier, 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 | 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 |
Recalls
7 of these are Class II. Class II means a temporary or reversible health consequence. Class III is unlikely to cause harm at all → typically a labelling or documentation fault. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-10-24 | Class III | Under Investigation by firm | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic. | 149 US | |
| 2021-04-28 | Class II | Environmental control | Exposed to freezing temperatures due to refrigerated truck malfunctions | 6 Cases | 2022-08-08 |
| 2020-09-12 | Class II | Device Design | The device may detect an incorrect Heater Bag volume which may lead to a ‘Supply Bag Line Blocked’ alarm during treatment. This alarm may cause the Heater Bag to contain more fluid than expected and the cycler does not recognize the extra f | 9,907 devices | |
| 2018-01-24 | Class II | Software design | The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or d | 9293 | 2020-05-11 |
| 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 |
| 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 |
| 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 |
| 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 |
| 2012-03-30 | Not classified | Software design | Increased risk of intraperitoneal volume (IIPV), referred to as Overfill | 10,146 units | 2016-08-04 |
| 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 |
| 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 |
| 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 |
| 2006-03-22 | Not classified | Other | Stay safe trigger body may not connect to the extension set and result in associated peritonitis | 141,770 units | 2006-07-11 |
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.