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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius LIBERTY 05087215 Automated Peritoneal Dialysis System Line Cycler Set

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 Class 2 Device Recall Fresenius LIBERTY 05087215 Automated Peritoneal Dialysis System Line Cycler Setsee related information
Date Initiated by FirmSeptember 03, 2010
Date PostedOctober 20, 2010
Recall Status1 Terminated 3 on February 16, 2023
Recall NumberZ-0104-2011
Recall Event ID 56675
510(K)NumberK043363 
Product Classification System, peritoneal, automatic delivery - Product Code FKX
ProductLIBERTY Automated Peritoneal Dialysis System Line Cycler Set with stay safe connectors (Single Patient Connector) PIN: 050-87215. manufactured for Fresenius Medical Care, Waltham MA by Erika de Reynoza, Reynosa Tampa, Mexico.
Code Information Lot Number Expiration Date 09CR08086 03/31/2012 09DR08038 04/30/2012 09JR08092 07/31/2012 09JR08093 07/31/2012 09KR08061 08/31/2012 
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 Commerce1524 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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