PlainRecalls
FDA Devices Moderate Class II Completed

Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

Reported: November 18, 2020 Initiated: September 12, 2020 #Z-0439-2021

Product Description

Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343

Reason for Recall

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.

Details

Units Affected
9,907 devices
Distribution
Distributed nationwide throughout the U.S and Puerto Rico. 9,907 devices currently in the field. 361 devices have been deactivated. 4,870 devices are ready to be shipped to customers along with the Urgent Medical Device Correction notice and response form.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled? ▼
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 9,907 devices.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 18, 2020. Severity: Moderate. Recall number: Z-0439-2021.

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