FDA Device recall Z-0439-2021
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
- FDA Device
- Class II
- completed
- Published 2020-11-18
On 2020-11-18 the FDA classified a Class II recall of Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343 by Fresenius Medical Care Holdings, citing 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 flui….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0439-2021 |
| Classification | Class II |
| Status | completed |
| Initiated | 2020-09-12 |
| Published | 2020-11-18 |
| Last updated | 2026-09-13 11:55 UTC |
| Company | Fresenius Medical Care Holdings |
| Distribution | US |
Product
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Reason
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 fluid is present and it will not make it available for treatment. Not having enough solution to complete treatment may lead to inadequate dialysis which could result in the accumulation of toxins and fluid. Symptoms may include shortness of breath, increased weight gain, and increased blood pressure.
Identifiers
| code_info | All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:55 UTC. Current status: completed.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0439-2021%22
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