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
|