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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 December 15, 2015
Date Posted January 27, 2016
Recall Status1 Terminated 3 on October 07, 2019
Recall Number Z-0693-2016
Recall Event ID 72926
510(K)Number K043363  K123630  
Product Classification System, peritoneal, automatic delivery - Product Code FKX
Product Fresenius Liberty Cycler-Peritoneal Dialysis Cycler
Model: 180111 and RTLR180111
Code Information All lot numbers
Recalling Firm/
Manufacturer
Fresenius Medical Care Renal Therapies Group, LLC
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
781-699-9000
Manufacturer Reason
for Recall
The door latch may not fully close and the door may open unexpectedly. The door may make physical contact with anything near the door of the machine, including the patient. May cause injury, delay in treatment, or Increased Intraperitoneal Volume (IIPV) (overfill).
FDA Determined
Cause 2
Device Design
Action Fresenius Medical Care issued on December 15, 2015, a n Important Product Notification to all affected customers informing them of the problem and how to recognize the proper latch closing. Questions regarding the contents of the Customer Notification or questions regarding the issue, contact Technical Services at 1-800-227-2572 and reference the Field Action Number FA-2015-10-W. A reply form is included as part of the customer communication with instructions to fill out and return via fax or scanned/emailed copy.
Quantity in Commerce 14,094 units
Distribution 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 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
510(K) Database 510(K)s with Product Code = FKX and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
510(K)s with Product Code = FKX and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA, DESIGN CENTE
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