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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius LIBERTY Cycler Sets 05087216, Automated Peritoneal Dialysis System lntegrated Cycler Set

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 Class 2 Device Recall Fresenius LIBERTY Cycler Sets 05087216, Automated Peritoneal Dialysis System lntegrated Cycler Setsee related information
Date Initiated by FirmSeptember 03, 2010
Date PostedOctober 20, 2010
Recall Status1 Terminated 3 on February 16, 2023
Recall NumberZ-0105-2011
Recall Event ID 56675
510(K)NumberK043363 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductLIBERTY 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.
Code Information 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		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information ContactKathleen Storro
800-662-1237
Manufacturer 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 2		Nonconforming Material/Component
ActionFresenius 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.
Quantity in Commerce5799 units
DistributionNationwide Distribution: Throughout USA.
Total Product Life CycleTPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database510(K)s with Product Code = FKX
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