Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for…
Medical device recall Z-1365-2018. Published in FDA’s Enforcement Report on Apr 18, 2018.
No Watch here, and no alerts: openFDA asks that its enforcement data “should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall” (openFDA). For FDA’s own recall emails, subscribe at FDA. FDA’s own record is on accessdata.fda.gov.
The short answer
Published in FDA’s Enforcement Report on Apr 18, 2018. Copied from openFDA on Oct 20, 2026.
- Class II FDA’s class
- Terminated its status, in FDA’s file
- Nationwide FDA’s word for where it went
- 9293 how much, in FDA’s words
Every line below is in FDA’s own words, with its source beside it. FDA’s terms are explained in FDA’s own words.
How serious is it, by FDA’s class?
Class II, the middle of FDA’s three classes.
“Products that might cause a temporary health problem, or pose only a slight threat of a serious nature. Example: a drug that is under-strength but that is not used to treat life-threatening situations.”
openFDA, in plain words, its enforcement report fields.
“Class II is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
FDA’s rule, 21 CFR 7.3(m)(2), eCFR.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
What’s wrong with it?
The recalling firm identified a software issue related to the Patient Line Check (PLC) which may result in an increased risk of Overfill (also known as Increased Intraperitoneal Volume, IIPV). Overfill/IIPV may result in serious injury or death.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Which ones are recalled?
Liberty Select Cycler (SW v.2.8.7), Material Number RTLR108343 Product Usage: The device is indicated for acute and chronic peritoneal dialysis.
9293, in FDA’s words.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Codes to check against yours
Serial Numbers: LC102494 LC013494 LC105025 LC018458 LC000876 LC008380 LC104548 LC017075 LC104397 LC014312 LC003306 LC015722 LC103879 LC105345 LC013863 LC105105 LC001731 LC020284 LC006439 LC013691 LC007915 LC103329 LC007321 LC023968…
Every code shown here, 1,996 characters
Serial Numbers: LC102494 LC013494 LC105025 LC018458 LC000876 LC008380 LC104548 LC017075 LC104397 LC014312 LC003306 LC015722 LC103879 LC105345 LC013863 LC105105 LC001731 LC020284 LC006439 LC013691 LC007915 LC103329 LC007321 LC023968 LC024113 LC105830 LC022009 LC102520 LC103883 LC105542 LC100857 LC104463 LC002679 LC003112 LC008814 LC023106 LC015078 LC020375 LC001669 LC010040 LC018692 LC002033 LC025214 LC000552 LC002895 LC014198 LC007063 LC100901 LC007381 LC021887 LC018820 LC004947 LC018792 LC021016 LC104232 LC020799 LC104339 LC012661 LC105175 LC104496 LC014929 LC105231 LC102218 LC102781 LC008363 LC014206 LC025287 LC007753 LC026180 LC101027 LC102512 LC105188 LC015687 LC023458 LC105896 LC103342 LC102526 LC104896 LC104628 LC103549 LC018183 LC009100 LC020103 LC104518 LC101890 LC006687 LC000843 LC013499 LC019400 LC105235 LC007159 LC025366 LC010069 LC004120 LC100082 LC102647 LC020593 LC024058 LC001762 LC020907 LC008540 LC103600 LC000479 LC020698 LC023463 LC022836 LC010744 LC021206 LC023369 LC013602 LC006308 LC025891 LC103047 LC026351 LC004203 LC026287 LC015659 LC022027 LC014231 LC016641 LC024679 LC011868 LC023604 LC015622 LC001105 LC104004 LC101499 LC015808 LC103556 LC019754 LC004454 LC020594 LC020430 LC020495 LC002417 LC018003 LC103174 LC019020 LC103769 LC016216 LC009691 LC104982 LC008740 LC024921 LC104194 LC014669 LC009900 LC010844 LC021561 LC000805 LC020024 LC001583 LC104805 LC104417 LC001277 LC022177 LC002125 LC105435 LC104893 LC017287 LC104507 LC012155 LC010884 LC005908 LC014903 LC014391 LC014786 LC002836 LC006304 LC011776 LC012757 LC024194 LC100388 LC023361 LC100979 LC021253 LC104578 LC014247 LC012168 LC023590 LC025636 LC010247 LC104972 LC105767 LC007907 LC016988 LC018377 LC101342 LC105758 LC003142 LC007052 LC024947 LC104675 LC106117 LC014399 LC021581 LC102110 LC010025 LC104838 LC014926 LC024161 LC104175 LC025129 LC019530 LC024871 LC019776 LC104271 LC011416 LC105034 LC001389 LC015052 LC105356 LC105661 LC017054 LC103002 LC009441 LC024649 LC016986 LC025131 LC101806…
FDA’s list runs to 83,654 characters. The first part is shown; the rest is on FDA’s record.
Copied exactly as FDA lists them: lot and serial numbers, dates and other codes on the product or its label.
Where did it go?
FDA’s words for the “general area of initial distribution”: where the firm first shipped it.
Nationwide distribution.
These words name no state.
What FDA means by nationwide
“The term “nationwide” is defined to mean the fifty states or a significant portion. Note that subsequent distribution by the consignees to other parties may not be included.”
openFDA, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
Is it still going on?
Terminated, in FDA’s file.
“FDA has determined that all reasonable efforts have been made to remove or correct the violative product in accordance with the recall strategy, and proper disposition has been made according to the degree of hazard.”
openFDA, on “Terminated”, its enforcement report fields.
What these words mean is quoted from openFDA’s field reference and 21 CFR 7.3.
- The firm began the recall on Jan 24, 2018.
- FDA classified it on Apr 11, 2018.
- FDA’s Enforcement Report published it on Apr 18, 2018.
- FDA terminated it on May 11, 2020.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
Who is recalling it?
- Fresenius Medical Care Renal Therapies Group, LLC, of Waltham, MA.
- Who began it, in FDA’s words: Voluntary: Firm initiated.
- How the firm first told its customers: Letter.
FDA, Device recall enforcement reports. Released Oct 14, 2026. Updated weekly.
What this record can’t tell you
- Whether your own one is affected: compare the codes, dates and numbers above with yours. When unsure, ask the firm or the store.
- Where it went after the firm’s first shipments. FDA’s words cover the firm’s initial distribution, and, in FDA’s words, “subsequent distribution by the consignees to other parties may not be included.”
- How many have been returned, corrected or destroyed: FDA’s report doesn’t say.
- Whether anyone was hurt or fell ill: the report doesn’t say.
- How current it is: openFDA publishes FDA’s Enforcement Report weekly, after FDA does, and a firm can announce a recall weeks before it appears there. openFDA’s own caution: “This data should not be used as a method to collect data to issue alerts to the public, nor should it be used to track the lifecycle of a recall.”
- FDA’s list of codes runs to 83,654 characters; the first part is shown here, and the rest is on FDA’s record.
- A product with no recall here isn’t safe by that: FDA’s report lists the recalls FDA classified, and when.
Hearth Record wrote these lines; the quotations are FDA’s.
Sources
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U.S. Food and Drug Administration, Device recall enforcement reports.
Released Oct 14, 2026 and checked Oct 20, 2026. Updated weekly. Public domain (CC0 1.0, openFDA). FDA asks that nothing suggest it endorses this site.
Recalls of food, medicines, medical devices, pet food and animal drugs are from the U.S. Food and Drug Administration (FDA). FDA does not endorse Hearth Record. openFDA: “Do not rely on openFDA to make decisions regarding medical care.” Copied on Oct 20, 2026.