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U.S. Department of Health and Human Services

Class 2 Device Recall Baxter Meridian Hemodialysis Instrument

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  Class 2 Device Recall Baxter Meridian Hemodialysis Instrument see related information
Date Initiated by Firm March 10, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on October 26, 2006
Recall Number Z-0758-04
Recall Event ID 28475
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
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		 Microbubbles of air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian.
FDA Determined
Cause 2		 Other
Action Urgent Device Correction letters dated 3/11/04 were sent to all Meridian users, informing them of adverse events associated with air in the extracorporeal blood circuit during hemodialysis therapy on the Meridian. The letter outlined the clinical practices that must be followed for all hemodialysis therapies to reduce the potential for air to be introduced into the extracorporeal blood circuit during hemodialysis. Any questions or related events to report were directed to Baxter Instrument Services at 1-800-553-6898, select prompt 3, option 2 and choice 2. Baxter developed a permanent fix -- an enhanced air detector with improved sensitivity, making it capable of detecting air bubbles of a smaller size. Letters were sent to all Meridian customers on 7/11/05, informing them of the availability of the new detector and that a Baxter Field Service Engineer would contact them to schedule the upgrade.
Quantity in Commerce 2,949 units
Distribution Nationwide, Mexico, China and Korea.
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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