Class 2 Device Recall Optiflux 180NR

• Date Initiated by Firm: December 03, 2007
• Date Posted: February 01, 2008
• Recall Status: Terminated 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/ Manufacturer: Fresenius Medical Care North America; 920 Winter St; Waltham MA 02451-1521
• For Additional Information Contact: 781-699-4475
• Manufacturer Reason for Recall: Leaking: the Dialyzer may leak at the header resulting in small amounts of blood loss.
• FDA Determined Cause: 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