Fresenius Liberty Cycler Sets Recalled


#1

Fresenius has recalled the Liberty Automated Peritoneal Dialysis System Cycler Sets.

The U.S. Food and Drug Administration announced a class II recall for certain lot numbers of Fresenius Medical Care’s Liberty Automated Peritoneal Dialysis System Cycler Sets because cycle set cassettes may leak due to holes or scratches in the film, contaminating dialysate and potentially resulting in peritonitis.

The FDA posted the following information Dec. 1 on its website:

Products

  1. LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Dual Patient Connector) PIN: 050-87212. Recall # Z-0103-2011;

  2. LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patient Connector) PIN: 050-87215. Recall # Z-0104-2011;

  3. LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. Recall # Z-0105-2011

Code

  1. Lot Number & Expiration Date
    09AR08026 1/31/2012
    09AR08045 1/31/2012
    09AR08046 11/30/2011
    09AR08092 1/31/2012
    09AR08093 1/31/2012
    09AR08103 1/31/2012
    09AR08104 01/31/2012
    09AR08119 11/30/2011
    09BR08034 02/29/2012
    09BR08035 2/29/2012
    09BR08036 02/29/2012
    09BR08037 2/29/2012
    09BR08038 02/29/2012
    09BR08050 2/29/2012
    09BR08051 02129/2012
    09BR08052 02129/2012
    09BR08073 02129/2012
    09BR08074 2/29/2012
    09BR08801 02/29/2012
    09BR08802 02/29/2012
    09BR08803 2/29/2012
    09CR08018 3/31/2012
    09CR08019 3/31/2012
    09CR08032 3/31/2012
    09CR08033 03/31/2012
    09CR08034 3/31/2012
    09CR08035 3/31/2012
    09CR08095 3/31/2012
    09DR08001 4/30/2012
    09DR08002 04/30/2012
    09DR08023 4/30/2012
    09DR08037 4/30/2012
    09DR08039 4/30/2012
    09DR08040 04130/2012
    09ER08093 05131/2012
    09ER08094 05131/2012
    09ER08095 05131/2012
    09ER08096 05131/2012
    09ER08097 5/31/2012
    09ER08104 05/31/2012
    09HR08072 06/30/2012
    09HR08073 6/30/2012
    09HR08074 06/30/2012
    09HR08099 06/30/2012
    09HR08100 06/30/2012
    09HR08101 6/30/2012
    09HR08130 06/30/2012
    09HR08131 06/30/2012
    09JR08016 07/31/2012
    09JR08017 07/31/2012
    09JR08018 07/31/2012
    09JR08019 7/31/2012
    09JR08095 07131/2012
    09JR08096 07131/2012
    09JR08097 713112012
    09JR08106 713112012
    09KR08007 813112012

  2. Lot Number Expiration Date
    09CR08086 03/31/2012
    09DR08038 04/30/2012
    09JR08092 07/31/2012
    09JR08093 07/31/2012
    09KR08061 08/31/2012

  3. Lot Number Expiration Date
    09ER08101 05/31/2012
    09HR08002 06/30/2012
    09HR08003 06/30/2012
    09JR08057 07/31/2012
    09JR08058 07/31/2012
    09JR08059 07/31/2012
    09KR08002 08/31/2012
    09KR08003 08/31/2012
    09KR08004 08/31/2012
    09KR08005 08/31/2012
    09LR08004 09/30/2012
    09LR08005 09/30/2012
    09LR08006 09/30/2012
    09LR08007 09/30/2012
    09LR08008 09/30/2012
    09LR08010 09/30/2012
    09LR08105 09/30/2012

Recalling firm/manufacturer

Recalling Firm: Fresenius Medical Care Holdings, Inc., Waltham, MA, by letter on September 3, 2010.
Manufacturer: Fresenius Medical Care, Tamulipas, Mexico. Firm initiated recall is ongoing.

Volume of product in commerce
370,588 units

Distribution
Nationwide