Class 3 Device Recall Meridian Hemodialysis Instrument

• Date Initiated by Firm: October 03, 2003
• Date Posted: June 30, 2005
• Recall Status: Terminated on July 01, 2005
• Recall Number: Z-0947-05
• Recall Event ID: 31870
• 510(K)Number: K992894
• Product Classification: Dialyzer, High Permeability With Or Without Sealed Dialysate System - Product Code KDI
• Product: Baxter Meridian Hemodialysis Instrument, product codes 5M5576 and 5M5576R; Baxter Healthcare Corporation, Renal Division, McGaw Park, IL 60085 U.S.A.
• Code Information: all serial numbers with software version 4.0 or below
• Recalling Firm/ Manufacturer: Baxter Healthcare Renal Div; 1620 Waukegan Rd Bldg R; Mc Gaw Park IL 60085-6730
• For Additional Information Contact: Center for One Baxter ; 800-422-9837
• Manufacturer Reason for Recall: The saline bags may inappropriately empty/fill during the recirculation mode of the hemodialysis system.
• FDA Determined Cause: Other
• Action: No official recall notificaiton was made. Meridian software version 4.12 was released on 10/3/03 and was implemented as a reliability improvement initiative to all Meridian customers. Shipment of 4.12 software was completed in November 2003.
• Quantity in Commerce: 2986 units
• Distribution: Nationwide, Korea, Mexico, Guatemala, China and Hong Kong
• 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