• Skip to primary navigation
  • Skip to main content
  • Skip to primary sidebar
  • Skip to footer

Drug Delivery Business

  • Clinical Trials
  • Research & Development
  • Drug-Device Combinations
  • FDA
  • Pharmaceuticals
  • Policy

BD applies to start shipping Alaris pumps again

April 26, 2021 By Nancy Crotti

BD Alaris infusion pump
(Image courtesy of BD)

BD (NYSE:BDX) said today that it has applied to the FDA for a new clearance for its recall-plagued Alaris infusion pump system.

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.

Filed Under: Drug-Device Combinations, Featured, Hospital Care, Regulatory/Compliance Tagged With: BD, FDA

IN CASE YOU MISSED IT

  • Shareholder lawsuit over BD’s Alaris pumps recall moves forward
  • Embecta stock soars on first full-quarter results after BD spinoff
  • Abbott will spend $450M to up FreeStyle Libre production in Ireland
  • Better Therapeutics Q2 beats Street as it prepares to submit diabetes therapy for FDA review
  • Study backs Fluidx embolic device for vessel filling

Primary Sidebar

MEDTECH 100 INDEX

Medtech 100 logo
Market Summary > Current Price
The MedTech 100 is a financial index calculated using the BIG100 companies covered in Medical Design and Outsourcing.
Need Drug Delivery Business News in a minute? We Deliver!
Drug Delivery Enewsletters get you caught up on all the mission critical news you need in med tech. Sign up today.

Signup for the newsletter

Footer

Drug Delivery Business News Logo

MassDevice Medical NETWORK

MassDevice
DeviceTalks
Medical Tubing & Extrusion
Medical Design & Outsourcing
MedTech100 Index
Drug Discovery & Development
Pharmaceutical Processing World
Medical Design Sourcing
R&D World

DRUG DELIVERY BUSINESS NEWS

Subscribe to Drug Delivery’s E-Newsletter
Advertise with us
About
Contact us
Privacy
Listen to our Weekly Podcasts
Add us on FacebookFollow us on TwitterConnect with us on LinkedIn

Copyright © 2022 · WTWH Media LLC and its licensors. All rights reserved.
The material on this site may not be reproduced, distributed, transmitted, cached or otherwise used, except with the prior written permission of WTWH Media.

Advertise | Privacy Policy | RSS