Recall Z-0439-2021— Fresenius Medical Care Holdings, Inc.
Class II · Completed
Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2020-09-12. It names one FDA 510(k) clearance: K171652. 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..
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Classification
- Class II
- Status
- Completed
- Initiated
- 2020-09-12
- Firm location
- Waltham, MA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.