Date Initiated by Firm |
October 12, 2012 |
Date Posted |
February 11, 2013 |
Recall Status1 |
Terminated 3 on December 30, 2020 |
Recall Number |
Z-0799-2013 |
Recall Event ID |
64175 |
510(K)Number |
K043363
|
Product Classification |
System, peritoneal, automatic delivery - Product Code FKX
|
Product |
Fresenius Liberty Cycler Set Single Conn. Ext. DL. Part Number: 050-87216.
Acute and chronic peritoneal dialysis. |
Code Information |
Lot 12BR08009 |
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 |
There is a small risk of a leak in Cycler Sets and if the Cycler Set is punctured, the dialysate may become contaminated potentially resulting in peritonitis.
|
FDA Determined Cause 2 |
Process control |
Action |
Fresenius Medical Care began contacting the affected customers by telephone and mailing an "URGENT: FMCNA LIBERTY CYCLER SET RECALL" letter and Return Receipt form dated October 31, 2012. The letters identified the specific part number and product lot and request that customers discontinue use of the lots immediately and to return unused product to FMCNA. Instructions are provided for returning the product, asking customers to isolate and discontinue use of the lot number 12BR08009 and place the product in a secure, segregated area. Consignees were instructed to contact their Fresenius Medical Care Customer Service Team at 1-800-323-5188 for instructions on how to return the recalled product. |
Quantity in Commerce |
560 cases, totaling 5590 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
|