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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Detail

Product Description 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.
Recall Number Z-1674-2013
Classification Class II
Code Info Lot 11PR08083
Product Distributed Qty 5480 units
Reason For Recall Cassette may leak during set up or during peritoneal dialysis treatment

Event Detail

Event Id 65332
Product Type Devices
Status Ongoing
Recalling Firm Fresenius Medical Care Holdings, Inc.
City Waltham
State MA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-03
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide Distribution