Recall Z-0619-2024 ยท FKX System, Peritoneal, Automatic Delivery
Fresenius Medical Care Holdings, Inc.
Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
| Date | Dec 26, 2023 (initiated Oct 24, 2023) |
| Status | Open, Classified |
| Reason | Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic. |
| Root cause | Under Investigation by firm |
| Action | Beginning October 24, 2023, the firm notified affected consignees via URGENT Medical Device Removal letters. Customers were instructed to reach out to their patients who had been identified as having affected cyclers to inform them that Fresenius's Technical Support team would be contacting them to arrange for a replacement. A second letter was sent to customers whose patients may potentially have affected cyclers. These customers were instructed to alert their patients of the incorrect time stamp issue. If the date and time on the patient treatment report does not match the time and date pr |
| Quantity | 149 US |
| Distribution | US Nationwide distribution in the states of AL, CA, FL, IL, IN, LA, MI, MO, MT, NC, NJ, NV, OH, OK, OR, PA, SC, TN, TX, VA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K222318 | Fresenius Liberty Select Cycler Fresenius Medical Care Renal Therapies Group, LLC, Oct 31, 2022 |