Recall Z-0799-2013— Fresenius Medical Care Holdings, Inc.

Name: FDA recall Z-0799-2013
Creator: U.S. Food and Drug Administration
Published: 2012-10-12

Class II · Terminated

Class II FDA medical device recall by Fresenius Medical Care Holdings, Inc., initiated 2012-10-12, terminated 2020-12-30. It names one FDA 510(k) clearance: K043363. Product: Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.. Reason: There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis..

Recalling firm: Fresenius Medical Care Holdings, Inc.
Classification: Class II
Status: Terminated
Initiated: 2012-10-12
Terminated: 2020-12-30
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 Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.

Reason for recall

There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.

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