Becton Dickinson Recalls Alaris Infusion Sets Due to Variations in Wall Thickness

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The Alaris Infusion Pump is used to deliver fluids into a person’s body through their vein in controlled amounts such as nutrients, medications, blood, and other therapies. The Alaris pump is used in hospitals and health care facilities.

Becton Dickinson Recalls Alaris Infusion Sets Due to Variations in Wall Thickness

Becton Dickinson recalled Alaris Infusion Sets due to variations in the wall thickness of the pumping segment of the machine. This variation may result in the pumping segment not be fully occluded by the pump. Non-uniform wall thickness can lead to non-uniform tubing collapse and can contribute to a failure to fully occlude the tubing. This issue caused a recall because it has the potential to lead to unintended delivery of medication when the pump module is not in running status. It can also result in faster than expected drug delivery flow when the pump is infusing. This may result in an over- infusion and the potential for serious patient injury or death, depending on the type of medication that is being delivered, since the issue may lead to flow inaccuracies through the pumping cycle process.

This recall has been associated with MDR reports, several of which are associated with serious injuries. The FDA considers this a Class I recall. This recall affects 151,139,816 products in the United States. These products were manufactured between May 1, 2016, and March 31, 2019, and distributed between July 1, 2016, and April 18, 2019.

Becton Dickinson has alerted and urged its customers to destroy all affected products.

Contact Regional Customer Quality if you require assistance at 844-823-5433 (CT) for general questions or Customer Advocacy at 888-812-3266 7AM to 5PM (PST) for product complaints/Adverse Event Reports.

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