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Recall Observatory FDA recall evidence

Device product

Fresenius Liberty Cycler Set Single Conn./Ext DL Product Number: 050-87216 Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line.

Z-1674-2013

June 03, 2013

Class II

Product summary

Firm
Fresenius Medical Care Holdings, Inc.
Event
Event 65332
Status
Terminated
Classification
Class II
Quantity
5480 units
Official record key
device-enforcement:Z-1674-2013

Official wording

Reason: Cassette may leak during set up or during peritoneal dialysis treatment

Code information: Lot 11PR08083

Distribution pattern: Nationwide Distribution

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Cassette may leak during set up or during peritoneal dialysis treatment