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
Hazard
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.
What You Should Do
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.
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Products
- Brand
- Fresenius Medical Care Renal Therapies Group, LLC
- UPC
- All lots
Units Affected
33732973 Cassettes; 18,674 Liberty Cyclers