Z-2151-2019Class II

Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis...

Name: Z-2151-2019 Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis...
Creator: Fresenius Medical Care Renal Therapies Group, LLC
Published: 2019-05-29
License: https://open.fda.gov/license/

Fresenius Medical Care Renal Therapies Group, LLC / initiated 2019-05-29 / Terminated

FDA source

Fresenius Medical Care Renal Therapies Group, LLC began a recall of Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as... on 2019-05-29. FDA classified it as Class II and gives the reason as "Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2151-2019
Classification: Class II
Status: Terminated
Initiated: 2019-05-29
Posted: 2019-08-05
Terminated: 2020-11-19
Recalling firm: Fresenius Medical Care Renal Therapies Group, LLC
Product: Liberty Cycler Cassettes (a disposable cassette that is intended to be used to perform peritoneal dialysis (APD) in conjunction with the Liberty cycler as follows: (1) LIBERTY Line Cycler Set with Stay-safe connectors (Dual Patient Connector) Part Number: 050-87212 (2) LIBERTY Line Cycler Set with Stay-safe connectors (Single Patient Connector) Part Number: 050-87215 (3) LIBERTY Integrated Cycler Set with single Stay-safe patient connector and extended drain line Part Number: 050-87216
Product code: FKX System, Peritoneal, Automatic Delivery
Reason for recall: Additional Instructions: step-by step handling and inserting the cassette into the Liberty Cycler set. A damaged cassette can cause peritoneal dialysis (PD) solution to leak into the cycler and is a potential risk for contamination.
FDA root cause: Use error
Action: Fresenius issued on 05/29/19 The IMPORTANT MEDICAL DEVICE INFORMATION notification explains to the Home Therapy Nurses/Clinics to review the new flyer with each of their APD patients who use a Liberty Cycler. For the patient notification, it will encourage them to use and follow the attached instructional flyer during set up for their daily dialysis treatment. The notification will have a copy of the new step-by-step instructional flyer. Included is a Reply Form for confirmation the consignee read and understands the notice sent to them.
Quantity in commerce: 33732973 Cassettes; 18,674 Liberty Cyclers
Distribution: US Nationwide Distribution
Product codes and lots: All lots

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2151-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2151-2019	Class II	Terminated	Voluntary: Firm initiated	2019-08-14	2019-08-05

Product code FKX

K173718Class IILiberty Cycler SetFresenius Medical Care Renal Therapies Group, LLC / cleared 2018-05-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)