Infusion Pumps
FDA Classifies Baxter's Field Corrective Action as a Class I Recall on Recently Manufactured or Upgraded Colleague Triple Channel Infusion Pumps (Models 2M8153, 2M8163 and 2M9163)
Published in Food and Drug Law Weekly, August 3rd, 2007
Baxter Healthcare Corporation announced that the U.S. Food and Drug Administration (FDA) has classified Baxter's field corrective action regarding recently manufactured or upgraded COLLEAGUE triple channel infusion pumps as a Class I recall. The company has identified a processing anomaly related to buffer overflow that occurs in specific situations. Baxter has received reports of 16 serious injuries that are associated with this issue at nine U.S. customer accounts.
The error occurs when all three channels are in use and a healthcare professional initiates a user interface-intensive command such as overriding the Guardian dose limit feature, displaying the dose mode...
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