Class 2 Device Recall Optiflux F250NRe Hemodialyzer

• Date Initiated by Firm: February 16, 2011
• Date Posted: March 22, 2011
• Recall Status: Terminated on February 12, 2013
• Recall Number: Z-1622-2011
• Recall Event ID: 57947
• 510(K)Number: K082414
• Product Classification: Dialyzer, High Permeability With or Without Sealed Dialysate System - Product Code KDI
• Product: Fresenius Optiflux F250NRe Hemodialyzer, Single Use, Catalog Number: 0500325E, Advanced Fresenius Polysulfone. Intended for use as an artificial kidney system to the treatment of patients with renal failure, fluid overload, or toxemic conditions by performing such therapies as hemodialysis, hemofiltration, hemoconcentration and hemodiafiltration.
• Code Information: Lot numbers: 10HU02012, Expiration Date: 06/30/2013; and 10LU02016, Expiration Date: 09/30/2013.
• Recalling Firm/ Manufacturer: Fresenius Medical Care Holdings, Inc.; 920 Winter St; Waltham MA 02451-1521
• For Additional Information Contact: Laura Howson; 800-669-9076
• Manufacturer Reason for Recall: There is an increased risk of an internal blood leak.
• FDA Determined Cause: Process control
• Action: FMCNA notified consignees on 2/16/11 by telephone and follow-up with an Urgent FMCNA Optiflux F250NRe Recall letter via Certified Mail, return Receipt requested. The firm states in the letter that there is an increased risk of an internal blood leak affecting a small percentage of the two lots of dialyzers. They are asking customers to examine their inventory, to discontinue use, and segregate the affected product in a secure place. Customers are to contact their FMCNA Customer Service Team at 1-800-323-5188 for instructions on how to return product. Used dialyzers should not be returned. If there are any questions, Customer Service should be contacted.
• Quantity in Commerce: 38,364 units
• Distribution: Worldwide Distribution -- USA and Canada.
• 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