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U.S. Department of Health and Human Services

Enforcement Report - Week of November 13, 2013

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Product Detail

Product Description Fresenius Liberty® Cycler Part Number: RTLR180111 Product Usage: The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
Recall Number Z-0148-2014
Classification Class II
Code Info All serial numbers
Product Distributed Qty 16,600
Reason For Recall Fluid leaking may be observed inside the pump compartment of the Liberty Cycler and may result in dialysate becoming contaminated, potentially causing peritonitis

Event Detail

Event Id 66339
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 2013-10-14
Initial Firm Notification of Consignee or Public Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern USA Nationwide Distribution