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Open, Classified

Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

FDA Recall Z-0619-2024 · Posted 2023-12-26

Recall StatusOpen, Classified
Product CodeFKX
Date Initiated2023-10-24
Product Quantity149 US

Reason for Recall

Affected Liberty Select cyclers may display an incorrect time stamp on the treatment data report sent to the clinic.

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 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

Distribution Pattern

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.

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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