FDA Recall Instituted after Company Fails to Address Injuries
UPDATED: February 7, 2020
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The U.S. Food & Drug Administration (FDA) has ordered Baxter Healthcare to recall and destroy all of its Colleague Volumetric Infusion Pumps, reimburse customers for the value of the recalled devices and assist customers in finding replacements. The recall was ordered after the medical device giant failed to address Colleague Pump 56,000 injuries and 500 deaths reported by patients and their families for years.
Colleague Volumetric Infusion Pump recall
The FDA ordered Baxter to recall and destroy all of its Colleague Volumetric Infusion Pumps – which are used to deliver fluids into a patients body in a controlled manner. According to the FDA, the pumps are widely used in hospitals, clinical settings and for in-home use because they are supposed to allow for a greater level of accuracy in fluid delivery.
However, the FDA said that there have been longstanding issues with Baxter's infusion pumps which it said are defectively designed, have software defects, user interface problems and are subject to mechanical and electrical failures. While the FDA has been working with Michigan-based Baxter Healthcare since 1999 to correct these issues, the company never stepped up to the plate.
The FDA obtained a consent decree of permanent injunction in 2006 in which Baxter finally agreed to stop manufacturing and distributing all models of the Colleague pump until it corrected manufacturing deficiencies and brought the devices into FDA compliance. The company did not comply and the FDA issued a Class I recallin April 2010. Baxter was given one more chance to fix the problems. It's solution was a letter to the FDA stating that it just couldn't address the issues right now.
Permanent injunction issued
Baxter's plan was to wait until 2012 to address these issues. That was unacceptable to the FDA which finally put its enforcement foot down, obtained a permanent injunction and forced the company to:
- Recall all of its Colleague Infusion Pumps – of which there are thought to be 200,000 in circulation
- Destroy the pumps once returned
- Reimburse customers for the value of the recalled device
- Assist in finding a replacement for these customers at no cost
Hospitals and other users of Baxter’s Colleague pumps will be receiving further instruction and information from Baxter and the FDA regarding their transition.
500 deaths / 56,000 serious injuries
FDA & Drug Litigation attorneys say that the company put profits over patient safety and point to FDA statements that the Administration has received more than 500 reports of death and 56,000 reports of serious injuries. If you've been injured by a defective Baxter Colleague Volumetric Infusion Pump, contact an experienced products liability lawyer in your state right away.