Date Initiated by Firm |
March 06, 2012 |
Date Posted |
March 30, 2012 |
Recall Status1 |
Terminated 3 on August 08, 2016 |
Recall Number |
Z-1339-2012 |
Recall Event ID |
61293 |
510(K)Number |
K003498
|
Product Classification |
Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
|
Product |
Fresenius Optiflux F160NRe Hemodialyzer Catalog number: 0500316E
Intended for patients with acute or chronic renal failure when conservative therapy is judged to be inadequate. |
Code Information |
Lot Number 11PU01012 Exp Date: 11/2014 |
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 |
Risk of internal blood leaks affecting the hemodialyzers.
|
FDA Determined Cause 2 |
Process control |
Action |
Fresenius North America notified consignees on 3/6/12 by recall notification letter titled:Urgent FMCNA Optiflux F160NRe Hemodialyzer Recall, by certified mail with return receipt. The letter identified the affected product and described the reason for the recall. Customers were instructed to examine their stock immediately to determine whether they have any of the affected lot on hand. If customers have the affected lot, they have been instructed to immediately discontinue use and place all unused units in a secure area for return to Fresenius Medical Care North America. A Reply Response from is to be completed and returned. Customers have been instructed to contact their Fresenius Medical Care Customer Service Team for instructions on how to return the recalled product. Contact 1-800-323-5188. |
Quantity in Commerce |
30,576 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.
|
510(K) Database |
510(K)s with Product Code = KDI and Original Applicant = FRESENIUS MEDICAL CARE NORTH AMERICA
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