Date Initiated by Firm | June 03, 2013 |
Date Posted | July 10, 2013 |
Recall Status1 |
Terminated 3 on June 18, 2014 |
Recall Number | Z-1674-2013 |
Recall Event ID |
65332 |
510(K)Number | K043363 |
Product Classification |
System, peritoneal, automatic delivery - Product Code FKX
|
Product | Fresenius Liberty Cycler Set Single Conn./Ext DL
Product Number: 050-87216
Automated Peritoneal Dialysis System with integrated stay safe patient connector and extended drain line. |
Code Information |
Lot 11PR08083 |
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 | Cassette may leak during set up or during peritoneal dialysis treatment |
FDA Determined Cause 2 | Unknown/Undetermined by firm |
Action | Fresenius Medical Care sent a Urgent Recall letter dated June 11, 2013, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer.
Customers were instructed to check their stock immediately and discontinue use and return product. Please contact your Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions to return the product. |
Quantity in Commerce | 5480 units |
Distribution | Nationwide Distribution |
Total Product Life Cycle | TPLC Device Report |
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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.
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510(K) Database | 510(K)s with Product Code = FKX
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