Device product

Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.

Z-0148-2014

October 14, 2013

Class II

Product summary

Firm: Fresenius Medical Care Holdings, Inc.
Event: Event 66339
Status: Terminated
Classification: Class II
Quantity: 16,600
Official record key: device-enforcement:Z-0148-2014

Official wording

Reason: Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis

Code information: All serial numbers

Distribution pattern: USA Nationwide Distribution

Derived failure modes

Unknown
reason.no_named_rule · v1.0.0

Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis