Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111
FDA device recall Z-0619-2024 · posted 2023-12-26 · Open, Classified
Recall details
- Recalling firm
- Fresenius Medical Care Holdings, Inc.
- Reason for recall
- Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.
- Action taken
- 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 provided from the patient's last treatment, instruct your patient to contact the Fresenius Medical Care Technical Support team if they would like to have their cycler replaced. If you need any further information or support concerning this issue, please contact Fresenius Technical Support at 1-800-227-2572, option 2, and reference the Field Action Number listed above.
- Root cause
- Under Investigation by firm
- Status
- Open, Classified
- Product code
- FKX
- Quantity affected
- 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.
- Date initiated
- 2023-10-24
- Date posted
- 2023-12-26
- Location
- Waltham, MA
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Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| Fresenius Liberty Select Cycler (K222318) | Fresenius Medical Care Renal Therapies Group, LLC | 2022-10-31 |