FDA-Device2013-02-20Class II

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

Fresenius Medical Care Holdings, Inc.
Hazard

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.

Sold states
Nationwide Distribution.
Affected count
560 cases, totaling 5590 units
Manufactured in
920 Winter St, Waltham, MA, United States
Products
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0799-2013

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