A manufacturing oversight has resulted in an FDA Class I recall of more than half a million infusion pumps across the U.S.
Becton Dickinson (BD) has issued a voluntary recall on its Alaris Pump Module Model 8100 Bezel Assembly. The device is an infusion pump that delivers fluids (e.g. medications, blood, blood products) into a patient’s body in controlled amounts.
The recall relates to the product’s six bezel posts, which connect the pumping mechanism frame to the bezel assembly and are critical to the device’s overall performance. From 2011 to 2017, the pump was manufactured with FR-110 plastic; however, the manufacturing process of the material resulted in its weakening, which may cause damage to the device’s bezel posts, including separation or cracking, and could lead to over-infusion, under-infusion, free-flow state, or interruption of infusion.
According to the U.S. Food and Drug Administration’s (FDA’s) Center for Veterinary Medicine (CVM), the recall was initially stated in August 2017 and was subsequently expanded in April 2018 to increase the volume of impacted product.
On Feb. 1, 2019, BD further expanded the recall to include all Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017.