Date Initiated by Firm |
November 28, 2005 |
Date Posted |
December 31, 2005 |
Recall Status1 |
Terminated 3 on August 10, 2006 |
Recall Number |
Z-0334-06 |
Recall Event ID |
34165 |
Product Classification |
Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
|
Product |
Optiflux Series Fresenius Polysulfone F180NR dialyzer High Flux Catalog Number: 0500318N |
Code Information |
Lot Number: 5LU319 |
Recalling Firm/ Manufacturer |
Fresenius Medical Care North America 95 Hayden Avenue Lexington MA 02421-7942
|
For Additional Information Contact |
Nicole Riek 781-402-9785
|
Manufacturer Reason for Recall |
Mislabeled: Inner product mislabeled as 180NR (Catalog Number 0500318N) instead of 160NR
|
FDA Determined Cause 2 |
Other |
Action |
Fresenius Medical notified consignees by letter dated 11/28/05 sent Certified Mail on 11/29/05 requesting return of product inventory. |
Distribution |
Nationwide |
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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