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
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Product | Optiflux Series Fresenius Polysulfone F160NR dialyzer High Flux
Catalog Number: 0500316N |
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 F180NR (Catalog Number 0500318N) instead of F160NR |
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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510(K) Database | 510(K)s with Product Code = KDI
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