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Terminated

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

FDA Recall Z-2151-2019 · Posted None

Recall StatusTerminated
Product CodeFKX
Date Initiated2019-05-29
Date Terminated2020-11-19
Product Quantity33732973 Cassettes; 18,674 Liberty Cyclers

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.

Firm 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.

Root Cause

Use error

Distribution Pattern

US Nationwide Distribution

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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