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U.S. Department of Health and Human Services

Class 3 Device Recall Fresenius Medical Care

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  Class 3 Device Recall Fresenius Medical Care see related information
Date Initiated by Firm November 28, 2005
Date Posted December 31, 2005
Recall Status1 Terminated 3 on August 10, 2006
Recall Number Z-0333-06
Recall Event ID 34165
510(K)Number K002277  
Product Classification Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
Product Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux
Catalog Number: 0500316N
Code Information Lot Number: 5LU319
Recalling Firm/
Fresenius Medical Care North America
95 Hayden Avenue
Lexington MA 02421-7942
For Additional Information Contact Nicole Riek
Manufacturer Reason
for Recall
Mislabeled: Inner product mislabeled as F180NR (Catalog Number 0500318N) instead of F160NR
FDA Determined
Cause 2
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

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