FDA Categorizes the BD Alaris Recall as Class I Event
IV Pump News July 25, 2019
On July 16, 2019, the FDA classified the Alaris Pump Module recall as a Class I event causing BD to accelerate their instructions for customer action as it relates to the inspection of bezels. This acceleration is an update to the notification of a recall expansion announced on April 15, 2019.
The recall, which was first announced in 2017, only affected pumps manufactured in October and November of 2011. The latest action by the FDA has increased the breadth of the recall to include pumps manufactured between 2011 and 2017. The bezels may contain weakened plastic components that cause the bezel posts to separate leading to the devices infusing more or less than the desired dose. According to the FDA’s Class I recall notice, there are 603,730 affected pump modules in commerce across the U.S. and around the world.
BD has divided the pumps into two categories based on likelihood of the pumps containing the weakened plastics. In a frequently asked questions (FAQs) document, BD recommends that biomedical engineers should inspect bezels of both Priority 1 and Priority 2 pumps as soon as possible. If damage is found the pump should be removed from service and BD should be contacted for a replacement. To date, there have been 14 patient injuries and all occurred with devices that fell into the Priority 1 category. The full list of FAQs and a customer notice can be found online at https://www.bd.com/en-us/support/recall-notifications/recall-notification-for-alaris-pump-module-bezel-post-separation-model-8100.
Pump modules and bezel replacement kits manufactured after June 2017 are not affected by this recall. The BD Alaris bezels are all manufactured with an improved plastic, and BD has tested them to ensure reliability. To date no injuries or complaints of cracking have been reported with the improved plastic.
For information on the initial recall from September 2017 visit: https://www.bd.com/en-us/support/recall-notifications/recall-notification-alaris-pump-module-model-8100.
AIV, Inc. is committed to providing high quality IV pumps, replacement parts, accessories and repair service for major infusion equipment manufacturers. Learn more about AIV’s wide selection of IV pump solutions at https://aiv-inc.com/iv-pump-parts-service.html.