Date Initiated by Firm |
February 04, 2014 |
Date Posted |
February 26, 2014 |
Recall Status1 |
Terminated 3 on May 18, 2021 |
Recall Number |
Z-1102-2014 |
Recall Event ID |
67313 |
510(K)Number |
K002761
|
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
|
Product |
Optiflux F200NRe High Flux Dialyzers; Product Number: 0500320E.
Single Use acute or chronic hemanalysis treatment. |
Code Information |
Lot Numbers: 13LU04022 13LU04021 13NU04003 13NU04005 13NU04018 13SU04002 |
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 |
Dialysate Port Leak During Priming of the Dialyzers
|
FDA Determined Cause 2 |
Under Investigation by firm |
Action |
Fresenius Medical issued Notice to Clinics and Clinics with Patients Letters Dated - 1st Mailing - February 4, 2014 and Patients Letters Dated - February 5, 2014 - these letters contained the correct information.Corrected letters to Clinics and Clinics with Patients issued 2/14/14 via certified mail with return receipt and fax-back form . Users are advised the leak may be stopped by tightening the dialysate port cap more securely.
Questions associated with this product notification to your Customer Service Team at 1-800-323-5188. |
Quantity in Commerce |
317,796 units |
Distribution |
Worldwide distribution: USA (nationwide) and the country of: Mexico. |
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 = KDI and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
|