FDAFDA · Food and drugs·Recall number Z-0799-2013
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
Published February 20, 2013 · Recall initiated: October 12, 2012
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Telephone
Recall details
- Manufacturer
- Fresenius Medical Care Holdings, Inc.
- Distributor
- Nationwide Distribution.
- Lot
- Lot 12BR08009
- Risk classification
- Class II
- Area (FDA)
- device
- Country
- United States
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