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Use caution Medical device recall · FDA · Published May 29, 2019

Fresenius Liberty Cycler Cassettes: Risk of PD Solution Leak from Damaged Cassettes

Fresenius Medical Care recalls Liberty Cycler Cassettes used in peritoneal dialysis due to potential leaks from damaged cassettes, risking contamination. Affected cassettes were sold with specific Liberty Cycler sets.

🇺🇸 FDA recall #Z-2151-2019Medical deviceFresenius Medical Care ›
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Recalling firmFresenius Medical Care Renal Therapies Group, LLC920 Winter St · Waltham, MA 02451-1521
✎ GovInfoNow plain-language explainer

Fresenius Medical Care recalls Liberty Cycler Cassettes used for peritoneal dialysis because damaged cassettes can leak dialysis solution into the machine, creating a contamination risk. This affects patients using the cassettes with specific Liberty Cycler sets. Read more at govinfonow.com/recall/67835-fresenius-liberty-cycler-cassettes-risk-of-pd-solution-leak-from.

Source Summary by GovInfoNow · govinfonow.com/recall/67835-fresenius-liberty-cycler-cassettes-risk-of-pd-solution-leak-from · Updated August 20, 2026 · FDA enforcement record: FDA #Z-2151-2019

Cite this page

“Fresenius Liberty Cycler Cassettes: Risk of PD Solution Leak from Damaged Cassettes.” GovInfoNow, updated August 20, 2026. https://govinfonow.com/recall/67835-fresenius-liberty-cycler-cassettes-risk-of-pd-solution-leak-from. Based on FDA recall #Z-2151-2019 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2151-2019%22&limit=1).

Fresenius Medical Care Renal Therapies Group, LLC voluntarily recalled Liberty Cycler Cassettes on May 29, 2019, according to the FDA. The agency announced the Class II recall due to a potential risk of contamination from damaged cassettes.

How to tell if you have it

  • Brand: Fresenius Medical Care
  • Product: Liberty Cycler Cassettes
  • Part Number: 050-87212 (LIBERTY Line Cycler Set with Stay-safe connectors, Dual Patient Connector)
  • Part Number: 050-87215 (LIBERTY Line Cycler Set with Stay-safe connectors, Single Patient Connector)
  • Part Number: 050-87216 (LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line)
  • Distribution: US Nationwide
  • Units affected: 33,732,973 Cassettes; 18,674 Liberty Cyclers

The hazard

A damaged cassette can cause peritoneal dialysis solution to leak into the cycler, creating a potential risk for contamination. The recall addresses issues related to step-by-step handling and inserting the cassette into the Liberty Cycler set.

Context

GovInfoNow's records show Fresenius Medical Care Renal Therapies Group, LLC has 15 other recalls on record since September 29, 2017. Other recent recalls of similar products include Fresenius Medical Care 5008X HD/HDF with CLiC Blood Tubing Set Recall (August 10, 2026), Fresenius Medical Care CombiSet Hemodialysis Tubing Set Recall (July 29, 2026), and Fresenius NaturaLyte Liquid Acid Concentrate Recall (July 14, 2026). Additional similar recalls include Fresenius Bicarby Dialysate Leaks Risk (May 12, 2026), ICU Medical CADD Yellow Medication Cassette Reservoir Recall (August 20, 2026), and Fresenius Kabi LVP-0004 Infusion Pump Recall (February 4, 2026).

How to tell if you have this one

Check if your cassette has a part number: 050-87212, 050-87215, or 050-87216. These cassettes were sold with Liberty Cycler sets for peritoneal dialysis.

  • Brand
    Fresenius Medical Care
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Cassette Condition

    Inspect your cassette for damage that could cause leaks, such as cracks or tears.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “US Nationwide Distribution” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: May 29, 201912. FDA classified it Class II: Aug 5, 201923. Published in FDA’s Enforcement Report: Aug 14, 201934. FDA terminated the recall: Nov 19, 2020420192020
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

Do I need to stop using the cassettes immediately?

The recall does not require immediate stop use; check for damage before continuing.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2151-2019 (May 29, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2151-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on August 20, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA