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U.S. Department of Health and Human Services

Class 2 Device Recall Optiflux 180NR

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  Class 2 Device Recall Optiflux 180NR see related information
Date Initiated by Firm December 03, 2007
Date Posted February 01, 2008
Recall Status1 Terminated 3 on February 08, 2008
Recall Number Z-0738-2008
Recall Event ID 46292
510(K)Number K002277  
Product Classification Hemodialyzer - Product Code KDI
Product Optiflux 180NR Advanced Fresenius Polysulfone, Catalog No.: 0500318E, Fresenius Medical Care North America, Waltham, MA 02451. (Hemodialyzer)
Code Information Lot # 7LU416
Recalling Firm/
Fresenius Medical Care North America
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
Manufacturer Reason
for Recall
Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.
FDA Determined
Cause 2
Process control
Action Consignees were notified by telephone and certified letter , Urgent Device Recall, on 12/03/2007. They were told to discontinue use and to return all unused affected dialyzers to Fresenius.
Quantity in Commerce 2,791 cases (33,492 dialyzers)
Distribution Nationwide including the states of AZ, CA, HI, IA, ID, IL, IN, KS, KY, MI, MN, MO, NE, NV, NY, OH, OR, PA, WA, and WI.
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