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Recall Observatory FDA recall evidence

Device product

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

Z-0799-2013

October 12, 2012

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 64175
Status
Terminated
Classification
Class II
Quantity
560 cases, totaling 5590 units
Official record key
device-enforcement:Z-0799-2013

Official wording

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.

Code information: Lot 12BR08009

Distribution pattern: Nationwide Distribution.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.