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Recalls

Alaris remediation could cost BD up to $244M

November 18, 2020 By Chris Newmarker

BD-logo-new

Becton Dickinson (NYSE:BDX) in its most recent fiscal year set aside $244 million to cover future product remediation costs, including the company’s work to fix its problematic Alaris infusion pumps. The Franklin Lakes, N.J.–based company has had shipments of the pumps on hold since early this year, when FDA called for a comprehensive 510(k) submission to […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls Tagged With: BD, Becton Dickinson

Baxter has a serious infusion pump recall

October 29, 2020 By Chris Newmarker

Baxter

Baxter (NYSE:BAX) has issued an urgent device correction involving hundreds of thousands of Sigma Spectrum infusion pumps in which it warns that improper cleaning could cause corrosion around the batteries. So far, Baxter has received 16 reports of serious injuries related to the problem. FDA has labeled the recall as Class I, its most serious level. […]

Filed Under: Featured, Food & Drug Administration (FDA), Recalls Tagged With: Baxter, infusion systems

BD warns on some ambulatory syringe pumps

February 25, 2020 By Sean Whooley

Becton Dickinson (NYSE:BDX) issued a field safety notice in the United Kingdom to warn on an issue with its T34 and T34L (T60) ambulatory syringe pumps. The company was alerted to an issue with the syringe pumps that could cause risk of under-infusion and/or alarm failure, according to the notice published today. Users of the syringe […]

Filed Under: Drug-Device Combinations, Featured, Recalls Tagged With: Becton Dickinson

Insulet’s Omnipod Dash Personal Diabetes Managers have a glitch

February 13, 2020 By Chris Newmarker

Insulet Ominipod Dash Personal Diabetes Managers

Insulet (NSDQ:PODD) is issuing a voluntary medical device correction for all of the smartphone-like Personal Diabetes Managers that came with its next-gen Omnipod Dash insulin management system, the company announced today. During its ongoing quality management process, Insulet officials discovered that the PDMs on rare occasions will suggest an inaccurate bolus amount based on a blood […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, mHealth (Mobile Health), Recalls Tagged With: Insulet, insulin

FDA says Medtronic MiniMed insulin pump recall is serious

February 12, 2020 By Chris Newmarker

Medtronic Minimed 630g

The U.S. FDA has designated a recall of hundreds of thousands of Medtronic Minimed insulin pumps as Class I — the most serious type of recall. Medtronic (NYSE:MDT) first warned of safety problems with the pumps in November. The recall involves 322,005 pumps — MiniMed 630G (model MMT-1715) and MiniMed 670G (model MMT-1780) — in the […]

Filed Under: Diabetes, Drug-Device Combinations, Featured, Recalls Tagged With: insulin, Medtronic

Teleflex recalls certain Arrow epidural catheterization kits in Europe

February 4, 2020 By Sean Whooley

Teleflex

Teleflex  (NYSE:TFX) subsidiary Arrow issued an urgent field safety notice in Europe to warn of failures with the loss of resistance (LOR) syringes including in epidural catheterization kits. The company received complaints regarding the syringes in the kits that revealed dural puncture with some also requiring a blood patch. An inadvertent dural puncture may lead […]

Filed Under: Drug-Device Combinations, Featured, Recalls Tagged With: teleflex

Smiths Medical recalls Medfusion 4000 due to issue with software update

December 19, 2019 By Sean Whooley

Smiths Medical

Smiths Medical has recalled its Medfusion 4000 syringe pump with Firmware version 1.7.0 due to malfunctioning alarms and potential interruption of therapy, FDA said today. The FDA has labeled the recall as Class I, it’s most serious designation. The Medfusion 4000 syringe pump is designed to deliver blood, blood products or prescribed drugs into a patient’s […]

Filed Under: Drug-Device Combinations, Featured, Food & Drug Administration (FDA), Recalls, Regulatory/Compliance Tagged With: FDA, Smiths Medical

Medicina recalls IV Luer Slip syringes

December 12, 2019 By Danielle Kirsh

medicina

Medicina is recalling its IV Luer Slip syringe due to incorrect packaging. According to the company, syringes were incorrectly packaged with a needle, which means they are not sterile and could cause a needle stick injury. The device affected by the recall is 3ml Luer Slip syringe without needle with Medicina product code IVS03, NHS […]

Filed Under: Drug-Device Combinations, Recalls Tagged With: Medicina

Medtronic warns patients of MiniMed insulin pump safety issue

November 22, 2019 By Nancy Crotti

Medtronic Minimed 630g

Medtronic (NYSE:MDT) is warning patients who use its MiniMed 600 series insulin pumps of an issue that could cause a dangerous over- or under-dosing of insulin. In a letter to patients, the company said that the pump’s insulin reservoir may become loose if a retainer ring breaks, preventing a proper lock. Dropping the pump or bumping […]

Filed Under: Diabetes, Featured, Food & Drug Administration (FDA), Recalls Tagged With: FDA, Medtronic, minimed

Whistleblowers accuse Fla. VA hospital of ignoring Alaris recall

August 27, 2019 By Sean Whooley

Staff members at a Florida U.S. Veterans Affairs Dept. hospital reportedly said leadership ignored the recall of the Alaris infusion pump made by Becton Dickinson (NYSE:BDX). Leaders at the James Haley Veterans’ Hospital in Tampa dismissed repeated warnings about BD’s device over multiple weeks, even after a patient’s life was endangered, the Military Times reported. […]

Filed Under: Featured, Hospital Care, Recalls Tagged With: Becton Dickinson

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