Class 2 Device Recall Optiflux F180NR Dialyzer

• Date Initiated by Firm: May 14, 2010
• Date Posted: July 01, 2010
• Recall Status: Terminated 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/ Manufacturer: Fresenius Medical Care North America; 920 Winter St; Waltham MA 02451-1521
• For Additional Information Contact: SAME; 800-662-1237
• Manufacturer Reason for Recall: Hemodialyzer may leak at the header/end cap
• FDA Determined Cause: 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