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Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

FDA Device Recall #Z-0619-2024 — Class III — October 24, 2023

Recall Summary

Recall Number Z-0619-2024
Classification Class III — Low risk
Date Initiated October 24, 2023
Status Ongoing
Voluntary Voluntary: Firm initiated

Recalling Firm

Firm Fresenius Medical Care Holdings, Inc.
Location Waltham, MA
Product Type Devices
Quantity 149 US

Product Description

Liberty Select Cycler, Model numbers RTLR180343 and RTLR180111

Reason for Recall

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

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.

Lot / Code Information

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

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Frequently Asked Questions

Contact your healthcare provider and the device manufacturer immediately. Check whether your specific model number and lot number are included in the recall scope. For external devices, stop using the affected product and arrange a replacement. For implanted devices, do not panic — removal is typically not required unless the risk assessment clearly indicates it. Your physician will guide you based on your individual clinical situation and the FDA's recommended actions. Report any adverse effects you may have experienced to FDA MedWatch at 1-800-FDA-1088.

Class I recalls indicate a reasonable probability of serious adverse health consequences or death from the defect. Class II recalls involve products that may cause temporary or medically reversible adverse health consequences, or where serious consequences are remote. Class III recalls cover products not likely to cause any adverse health consequences, typically involving technical regulatory violations. The classification guides urgency — Class I recalls require immediate action, while Class III may simply involve returning a product or acknowledging a labeling change. Always read the specific recall notice for recommended patient actions.

Report problems with medical devices to the FDA through MedWatch at 1-800-FDA-1088 or online at FDA.gov/safety/medwatch. Healthcare facilities are required by law to report device-related serious injuries and deaths. Patients and consumers can also report voluntarily. Include the device name, manufacturer, model number, and a description of the problem and any patient outcome. Reports from patients and clinicians help the FDA identify emerging safety signals and may trigger investigations that lead to recalls of dangerous devices.

What Should You Do?

Stop using this device if you are affected by this recall. Contact your healthcare provider and the manufacturer immediately for guidance. Report adverse events to FDA MedWatch.

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