Class 2 Device Recall Fresenius

• Date Initiated by Firm: May 24, 2013
• Date Posted: July 11, 2013
• Recall Status: Terminated on October 07, 2019
• Recall Number: Z-1693-2013
• Recall Event ID: 65090
• 510(K)Number: K080964 K093902 K101715 K111639 K113427 K120505
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: Fresenius Service Replacement 0-Ring. Used in as a service part in 4 sub-assemblies manufactured and/or refurbished Fresenius hemodialysis machines, models 2008K, 2008K2, 2008K@Home and 2008T
• Code Information: Part Number: 640919
• Recalling Firm/ Manufacturer: Fresenius Medical Care Holdings, Inc.; 920 Winter St; Waltham MA 02451-1521
• For Additional Information Contact: SAME; 800-662-1237
• Manufacturer Reason for Recall: Incorrect rubber nitrile O-rings distributed instead of the correct material EPDM. (Ethylene Propylene Dine Monomer (M-class) rubber)
• FDA Determined Cause: Nonconforming Material/Component
• Action: Fresenius notified customers on May 24, 2013, by telephone and by certified mail with signature confirmation and fax-back form. Customers were instructed to examine their stock immediately to determine whether they have any of the affected parts on hand. If customers have the affected parts, they will be instructed to immediately discontinue use and place all 0-rings in a secure area for return to Fresenius Medical Care North America. Please contact your Fresenius Medical Care Technical Service Team at 1-800-227-2572, (choose option 4, then option 2) for instructions how to return the recalled product.
• Quantity in Commerce: 725 units
• Distribution: Nationwide Distribution including the states of AR, CA, FL, GA, KY, LA, MA, MD, NC, NJ, NY, PA, PR, SC, TX and VA.
• 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; 510(K)s with Product Code = KDI; 510(K)s with Product Code = KDI