![]() The cookie is used to store the user consent for the cookies in the category "Analytics". This cookie is set by GDPR Cookie Consent plugin. ![]() These cookies ensure basic functionalities and security features of the website, anonymously. 1, 2019, BD further expanded the recall to include all Alaris Pump Modules Model 8100 manufactured between April 2011 and June 2017.Īffected customers are asked to follow the instructions for inspection of their pumps (click here for more), or contact the BD support center at cookies are absolutely essential for the website to function properly. 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. 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.Īccording to the U.S. 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. medications, blood, blood products) into a patient’s body in controlled amounts. ![]() The device is an infusion pump that delivers fluids ( e.g. 3) Back side of bezel assembly highlighting the bezel posts.Ī manufacturing oversight has resulted in an FDA Class I recall of more than half a million infusion pumps across the U.S.īecton Dickinson (BD) has issued a voluntary recall on its Alaris Pump Module Model 8100 Bezel Assembly. 2) Pump module door open showing the front of the bezel. 1) Two pump modules with attached Alaris PC unit.
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