Recall Z-0148-2014— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0148-2014
Creator: U.S. Food and Drug Administration
Published: 2013-10-14

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2013-10-14, terminated 2021-05-18. It names one FDA 510(k) clearance: K043363. Product: Fresenius Liberty¿ Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.. Reason: Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis.

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2013-10-14
Terminated: 2021-05-18
Firm location: Waltham, MA, United States

510(k) clearances named in this recall

1 on FDA's record

K043363 — FRESENIUS LIBERTY CYCLERFresenius Medical Care North America·cleared 2005-03-31

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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

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

Data sourced from openFDA. This site is unofficial and independent of the FDA.