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U.S. Department of Health and Human Services

Class 2 Device Recall Fresenius Optiflux F160NR High Flux Dialyzers

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  Class 2 Device Recall Fresenius Optiflux F160NR High Flux Dialyzers see related information
Date Initiated by Firm February 04, 2014
Date Posted February 26, 2014
Recall Status1 Terminated 3 on May 18, 2021
Recall Number Z-1099-2014
Recall Event ID 67313
510(K)Number K002277  
Product Classification Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
Product Optiflux F160NR High Flux Dialyzers; Product Number: 0500316N.

Single Use acute or chronic hemanalysis treatment.
Code Information Lot Numbers: 13NU01014 13SU01001 13SU01002 
Recalling Firm/
Manufacturer		 Fresenius Medical Care Holdings, Inc.
920 Winter St
Waltham MA 02451-1521
For Additional Information Contact
800-662-1237
Manufacturer Reason
for Recall		 Dialysate Port Leak During Priming of the Dialyzers
FDA Determined
Cause 2		 Under Investigation by firm
Action Fresenius Medical issued Notice to Clinics and Clinics with Patients Letters Dated - 1st Mailing - February 4, 2014 and Patients Letters Dated - February 5, 2014 - these letters contained the correct information.Corrected letters to Clinics and Clinics with Patients issued 2/14/14 via certified mail with return receipt and fax-back form . Users are advised the leak may be stopped by tightening the dialysate port cap more securely. Questions associated with this product notification to your Customer Service Team at 1-800-323-5188.
Quantity in Commerce 6720 units
Distribution Worldwide distribution: USA (nationwide) and the country of: Mexico.
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
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