PlainRecalls
FDA Devices Moderate Class II Terminated

Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.

Reported: February 20, 2013 Initiated: October 12, 2012 #Z-0799-2013

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.

Details

Units Affected
560 cases, totaling 5590 units
Distribution
Nationwide Distribution.
Location
Waltham, MA

Frequently Asked Questions

What product was recalled?
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.. Recalled by Fresenius Medical Care Holdings, Inc.. Units affected: 560 cases, totaling 5590 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Devices on February 20, 2013. Severity: Moderate. Recall number: Z-0799-2013.