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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius

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  Class 2 Device Recall Fresenius see related information
Date Initiated by Firm October 14, 2013
Date Posted November 05, 2013
Recall Status1 Open3, Classified
Recall Number Z-0148-2014
Recall Event ID 66339
510(K)Number K043363  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Fresenius Liberty¿ Cycler
Part Number: RTLR180111

Product Usage:
The Liberty cycler is a portable device designed to perform acute and chronic peritoneal dialysis.
Code Information All serial numbers
Recalling Firm/
Manufacturer
Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer 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
FDA Determined
Cause 2
Device Design
Action Fresenius Medical Care contacted all affected consignees by telephone on 10/14/13 to inform them of the product safety alert. Follow-up Urgent Safety Alert letter was sent on 10/18/13 and 10/23/13 by Certified Mail, Return Receipt requested. The letter identified the affected product, problem and actions to be taken. Customers were instructed to report any events associated with this safety alert to Customer Service Team at 1-800-323-5188.
Quantity in Commerce 16,600
Distribution USA Nationwide Distribution
Total Product Life Cycle TPLC 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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FKX and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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