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U.S. Department of Health and Human Services

Class 2 Device Recall Optiflux F180NR Dialyzer

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  Class 2 Device Recall Optiflux F180NR Dialyzer see related information
Date Initiated by Firm May 14, 2010
Date Posted July 01, 2010
Recall Status1 Terminated 3 on September 13, 2011
Recall Number Z-1951-2010
Recall Event ID 55771
510(K)Number K002277  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Optiflux¿ F180NR Dialyzers, Catalog Number: 0500318E. Manufactured by Fresenius Medical Care North America, Ogden, UT 84404.

Designed for single use acute and chronic hemodialysis.
Code Information Lot Number: 10AU04011, Exp 01/13.
Recalling Firm/
Fresenius Medical Care North America
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact SAME
Manufacturer Reason
for Recall
Hemodialyzer may leak at the header/end cap
FDA Determined
Cause 2
Process control
Action Fresenius Medical notified customers by telephone script beginning May 14, 2010 and follow up letter advising users to examine inventory for recalled lot, discontinue use and contact Fresenius Customer Care 1-800-325-5188 , ext. 6610 for instructions on how to return the recalled product.
Quantity in Commerce 34,152 units
Distribution Nationwide Distribution
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