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FDA Announces Class I Recall of Baxter Healthcare's Colleague Volumetric Infusion Pumps
FDA Class 1 Recall: Baxter Healthcare Corp. COLLEAGUE® and FLO-GARD® Volumetric Infusion Pumps
Baxter Healthcare Corp. in association with the FDA has recently issued a Class 1, worldwide recall of the COLLEAGUE® Volumetric Infusion Pump because they can shut down while delivering critical medication and fluids to patients. According to the FDA, Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem.
Class 1 recalls are the most serious type of recall and involve situations in which there is a reasonable probability that use of the product will cause serious injury or death.
If you or a loved one have been injured by the Baxter COLLEAGUE® Volumetric Infusion Pump recall, you should contact us immediately. You may be entitled to compensation and we can help.
Approximately 255,000 Colleague® Volumetric Infusion Pumps are currently in use, including 206,000 distributed in the United States. They have been sold to physicians, hospitals, pharmacies, and a variety of other medical facilities.
The FDA announced that Baxter Healthcare Corp. initiated a worldwide recall of all models of its Colleague® Volumetric Infusion Pumps because they can shut down while delivering critical medication and fluids to patients. Baxter has received six reports of serious injury and three reports of death associated with this shut-down problem.
UPDATE (7/27/07): Baxter contacted their customers informing them that the company discovered, during ongoing quality control processes, that repair, test and inspection data sheets, including electrical safety data, were falsified.
As a result, it may be possible that pumps sent to be serviced, repaired, or corrected were returned without service being performed on them. This may result in over infusion, under infusion, failure to detect an upstream or downstream occlusion, electrical shock hazard, failure to detect air in line and malfunctions where the pump will stop infusing and result in an interruption of therapy that can result in death.
All of the following model numbers of the Baxter COLLEAGUE® Volumetric Infusion Pump are subject to recall.
The Medical Device and Product Liability Litigation Group at our law firm is an experienced team of trial lawyers that focus exclusively on the representation of plaintiffs in defective medical device recall lawsuits. We are currently investigating the possibility of handling individual Baxter COLLEAGUE® Volumetric Infusion Pump recall litigation nationwide and currently accepting new Baxter recall claims in all 50 states.
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