BD has had shipments of Alaris pumps on hold after the FDA called for a comprehensive 510(k) submission to cover a host of software fixes needed following a Class I-level recall in March 2020. Pumps are only going to health providers with an immediate medical need.
In November, BD disclosed that it set aside $244 million to cover future product remediation costs, including its effort to fix the problematic Alaris pumps. The company said at the time that it planned to submit the 510(k) in late Q2 or early Q3 (around spring 2021).
Franklin Lakes, N.J.-based BD said it applied for the new 510(k) clearance to implement updated features and address open recall issues, including through a new version of Alaris software that will provide clinical, operational and cybersecurity updates.
The two most recent recalls — both labeled Class I by the FDA — involved a risk of the keypad lifting due to fluid entry, an issue that could result in keys that become unresponsive or stuck and the risk the bezel repair posts may crack or separate, leading to the inaccurate delivery of fluids to patients. BD initiated those recalls in February and March, respectively.
“Today marks an important milestone in our commitment to our customers and patients and Advancing the world of health™,” said Michael Garrison, BD’s worldwide president of medication management solutions, in today’s news release. “The 510(k) submission is the first step in the review process with the FDA, and we look forward to working through the FDA review process to obtain clearance for the updated BD Alaris system.”
BD’s Alaris system is an infusion pump and vital signs monitoring system designed to deliver fluids, medications, blood and blood products in controlled amounts.
Shares of BDX were up 0.86% to $258.04 apiece in mid-afternoon trading. MassDevice‘s MedTech 100 Index, which includes the stocks of the world’s largest medical device companies, is about the same as is the Dow Jones Industrial Average.