FDAClass IIFebruary 20, 2013

Fresenius Liberty Cycler Set Single Conn. Ext. DL recall: Contamination

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

Why was Fresenius Liberty Cycler Set Single Conn. Ext. DL 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.

What should I do if I have this product?

Review the official FDA enforcement record for current instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot 12BR08009

Product
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216. Acute and chronic peritoneal dialysis.
Recalling firm
Fresenius Medical Care Holdings, Inc.
Quantity
560 cases, totaling 5590 units
Distribution
Nationwide Distribution.
Recall date
February 20, 2013
Classification
Class II
Status
Terminated
Agency
FDA (device)
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