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U.S. Department of Health and Human Services

Class 3 Device Recall Meridian Hemodialysis Instrument

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  Class 3 Device Recall Meridian Hemodialysis Instrument see related information
Date Initiated by Firm October 03, 2003
Date Posted June 30, 2005
Recall Status1 Terminated 3 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 2		 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 and Original Applicant = BAXTER HEALTHCARE CORP.
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