Class 2 Device Recall Fresenius ASSEMBLY, POWER SUPPLY

• Date Initiated by Firm: December 16, 2014
• Date Posted: January 27, 2015
• Recall Status: Terminated on January 29, 2021
• Recall Number: Z-1015-2015
• Recall Event ID: 70027
• 510(K)Number: K121341 K121421 K994267
• Product Classification: Dialyzer, high permeability with or without sealed dialysate system - Product Code KDI
• Product: ASSY, POWER SUPPLY 130V 50HZ. This component is used with the following machines: 2008T Hemodialysis Machine, 2008K Hemodialysis Delivery Equipment, 2008 K2 Hemodialysis Delivery Equipment 2008K@home Hemodialysis Delivery System
• Code Information: 4P¿226813; 4P¿226815; 4P-226817; 4P-226818; 4P¿226819; 4P-226820; 4P-226821; 4P-226822
• Recalling Firm/ Manufacturer: Fresenius Medical Care Holdings, Inc.; 920 Winter St; Waltham MA 02451-1521
• For Additional Information Contact: 800-227-2572
• Manufacturer Reason for Recall: Unqualified power assemblies shipped to customers.
• FDA Determined Cause: Under Investigation by firm
• Action: Consignees were notified of the recall via letter sent on 12/18/2014 via certified mail. The letter informs consignees of the recall and requests that they take the following steps: Please check your stock for any 50 Hz Power Supplies (P/N 190092) with the name Electro Assemblies, LLC which is visible on the Transformer contained inside the Power Supply and discontinue use. Place the product in a secure, segregated area. Please contact your Fresenius Technical Services at 1-800-227-2572 option 4 then option 1, and reference the Field Action Number above. They will issue you a Return Good Authorization so you can return this product. that a reply form is completed and returned via fax or scanned email copy. In addition, consignees are asked to complete a reply form and return via fax/mail.
• Quantity in Commerce: 10
• Distribution: Distributed in OK and FL.
• 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