Date Recall |
September 28, 2005 |
Product: |
Baxter Meridian® Hemodialyis (HD) Instrument (Product Codes 5M5576 and 5M5576R) |
Use: |
The Baxter Meridian® is a single patient hemodialysis instrument that prepares dialysis solution, circulates blood through an external tubing system and hemodialyzer, and monitors the system for operating conditions. |
Recalling Firm: |
Baxter Healthcare Corporation |
Reason for Recall: |
There have been reports of hemolysis (broken blood cells) related to kinks in the blood tubing sets used with the Meridian®. To date, there have been reports of at least one death and one serious injury, associated with kinking of blood tubing sets routed through both channels of the two channel clips mounted on the front of the Meridian®. The original labeling for the device is inadequate because it instructs users to route the blood tubing sets through both channels of the two-channel clips. |
Public Contact: |
Center for One Baxter |
FDA District: |
Chicago |
FDA Comments: |
|
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Consumers with questions about the recall may contact the company at (800) 422-9837. Those who have technical questions may contact the company at (800) 553-6898. Baxter's letters to customers and press releases are available on its web site at www.Baxter.com. |
Updated December 19, 2005
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