Liberty Select Cycler, Model numbers RTLR180343 and… recallZ-0619-2024 · Fresenius Medical Care Holdings, Inc. · initiated Oct 24, 2023

Open, Classified

Is my device affected?

Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
If yours is listed, follow the instructions from Fresenius Medical Care Holdings, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.

Where to find your model and lot numbers · What recall classes and statuses mean

Why it was recalled

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

FDA root cause category: Under Investigation by firm

What the company is doing

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.

Recall details

Recall number: Z-0619-2024
Status: Open, Classified
Initiated by the company: Oct 24, 2023
Posted by the FDA: Dec 26, 2023
Recalling firm: Fresenius Medical Care Holdings, Inc.
Quantity: 149 US
Product code: FKX
FDA submissions: K222318
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.

Product description

Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

Code information (models, lots, serial numbers)

Show the full code information (1k characters)

UDI-DI 00840861102068 Serial Numbers LC002956 LC102178 LC021724 LC107205 LC023197 LC021734 LC017434 LC108957 LC022069 LC103031 LC006834 LC022218 LC017378 LC026229 LC022262 LC104084 LC005140 LC022616 LC019115 LC021388 LC024210 LC108220 LC020906 LC024377 LC023711 LC121383 LC025541 LC118552 LC010607 LC025545 LC015082 LC111682 LC026353 LC114222 LC105047 LC102656 LC113355 LC104022 LC103069 LC115736 LC109288 LC104268 LC016965 LC121349 LC104371 LC105964 LC003341 LC104630 LC016669 LC113929 LC105108 LC020357 LC111447 LC105656 LC003460 LC112030 LC105951 LC107408 LC025450 LC106453 LC109867 LC012490 LC107813 LC108319 LC106079 LC108527 LC106667 LC122086 LC108652 LC110922 LC119859 LC108929 LC022708 LC010574 LC108988 LC113343 LC118563 LC109815 LC000539 LC105216 LC110210 LC108637 LC103326 LC112490 LC103658 LC104946 LC112954 LC024150 LC017621 LC113920 LC017046 LC017185 LC114230 LC022051 LC010500 LC117266 LC001887 LC002982 LC117324 LC102332 LC106468 LC117470 LC007590 LC100108 LC118836 LC016220 LC101309 LC120508 LC018125 LC010096 LC121590 LC022514 LC018533 LC121788 LC009410 LC002257 LC122822 LC105569 LC002521 LC116979 LC004607 LC006643 LC004836 LC109482 LC008971 LC115908 LC009077 LC123137 LC010282 LC102959 LC010363 LC020163 LC011334 LC107982 LC013964 LC118817 LC015496 LC118029 LC015554 LC119978 LC017329 LC104633 LC017436 LC020459 LC019811 LC110544 LC020468 LC113118 LC021140

Devices named in this recall

1 device in the FDA device registry whose identifier appears in the recall's code information.

Liberty® Select Cycler 180343
Fresenius Medical Care Holdings, Inc. · System, peritoneal, automatic delivery
1 recall545 deaths15,896 reports

Sources and updates

Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.

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