Recall Z-0105-2011

Fresenius Medical Care Holdings, Inc. · initiated September 3, 2010

Terminated

Product

LIBERTY Automated Peritoneal Dialysis System lntegrated Cycler Set with single stay safe patient connector and extended drain line PIN: 050-87216. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.

Codes / lots: 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

Reason for recall

Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially resulting in peritonitis.

FDA-determined cause: Nonconforming Material/Component

Action taken

Fresenius Medical Care issued an Urgent FMCNA LIBERTY Cycler Set Recall letter on September 3, 2010 identifying the specific affected part numbers and product lots and requesting that customers identify and discontinue the use of the affected lots immediately. Customers were requested to return a receipt of notification. Customers may arrange return unused product to FMCNA by contacting customer service at 1-800-323-5188.

Details

Recall number
Z-0105-2011
Initiated
September 3, 2010
Posted by FDA
October 20, 2010
Terminated
February 16, 2023
Product code
FKX – System, Peritoneal, Automatic Delivery
Quantity
5799 units
Distribution
Nationwide Distribution: Throughout USA.
Recalling firm
Fresenius Medical Care Holdings, Inc., Waltham, MA

Official FDA recall record

Other products in the same recall event

RecallProductInitiated
Z-0103-2011 LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors…Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially… 09/03/2010Terminated
Z-0104-2011 LIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors…Cycle set cassettes may leak due to holes/scratches in the film, contaminating dialysate and potentially… 09/03/2010Terminated