Fresenius Liberty Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
This recall has been terminated (originally issued November 5, 2013).
- Recall Initiated
- October 14, 2013
- Posted
- November 5, 2013
- Terminated
- May 18, 2021
- Recall Number
- Z-0148-2014
- Quantity
- 16,600
- Firm Location
- Waltham, MA
- Official Source
- View on FDA website ↗
Reason for Recall
Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis
Distribution
USA Nationwide Distribution
Lot / Code Info
All serial numbers
Root Cause
Device Design
Action Taken
Fresenius Medical Care contacted all affected consignees by telephone on 10/14/13 to inform them of the product safety alert. Follow-up Urgent Safety Alert letter was sent on 10/18/13 and 10/23/13 by Certified Mail, Return Receipt requested. The letter identified the affected product, problem and actions to be taken. Customers were instructed to report any events associated with this safety alert to Customer Service Team at 1-800-323-5188.