Liberty Select Cycler Software Version 2.9.0 recall
Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
Why was Liberty Select Cycler Software Version 2.9.0 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.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Liberty Select Cyclers with Software Version 2.9.0 Model Number 180343 and RTLR180343
- Product
- Liberty Select Cycler Software Version 2.9.0 Model Number 180343 and RTLR180343
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Quantity
- 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.
- Recall date
- November 18, 2020
- Classification
- Class II
- Status
- Completed
- Agency
- FDA (device)