Baxter’s Colleague Consent Decree Enjoins Sales, Expands Obligations
This article was originally published in The Gray Sheet
Executive Summary
Baxter signed a consent decree with FDA June 29 forbidding the sale of its widely used but malfunction-prone Colleague intravenous infusion pump until the firm complies with manufacturing quality regulations
You may also be interested in...
FDA Hits Baxter With Two Warning Letters In Four Weeks
The warning letters cite quality system regulation violations related to the firm’s infusion pumps, including inadequate corrective and preventive actions related to complaints of over-infusion and device bladder ruptures.
Mandatory Baxter Infusion Pump Recall Will Cost Up To $600 Million
Baxter will recall all of its Colleague infusion pumps on the U.S. market at an initial cost of up to $600 million, the firm disclosed May 3
Mandatory Baxter Infusion Pump Recall Will Cost Up To $600 Million
Baxter will recall all of its Colleague infusion pumps on the U.S. market at an initial cost of up to $600 million, the firm disclosed May 3