Medical device recall

Becton Dickinson Recalls More than 151 Million Alaris Infusion Sets

By MedTech Intelligence Staff
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Medical device recall

A product malfunction could cause potential over-infusion or unintended delivery of medication.

Becton Dickinson (BD) has recalled its Alaris Pump Model 8100 Infusion Sets after discovering there is potential for the pump to administer medication faster than expected or unintentionally. Used in hospitals and healthcare facilities, the pumps are intended to deliver fluid from an infusion tubing set to a patient’s vein. “The firm has determined that the silicone segment of the affected administration set has non-uniform thickness. Non-uniform wall thickness can lead to non-uniform tubing collapse and can contribute to a failure to fully occlude the tubing,” according to the recall alert on FDA’s website. The product defect can cause serious adverse health consequences, including death. Several serious injuries have been reported.

The Class I recall affects 151,139,816 products in the United States. They were manufactured between May 1, 2016 and March 31, 2019 and distributed between July 1, 2016 and April 18, 2019.

On May 6, BD sent its customers an Urgent Medical Device Recall informing them of the products affected by the recall and instructing them to destroy all affected products.

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