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 […]
Insulet’s Omnipod Dash Personal Diabetes Managers have a glitch
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 […]
FDA says Medtronic MiniMed insulin pump recall is serious
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 […]
Teleflex recalls certain Arrow epidural catheterization kits in Europe
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 […]
Smiths Medical recalls Medfusion 4000 due to issue with software update
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 […]
Medicina recalls IV Luer Slip syringes
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 […]
Medtronic warns patients of MiniMed insulin pump safety issue
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 […]
Whistleblowers accuse Fla. VA hospital of ignoring Alaris recall
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. […]
BD updates infusion pump recalls
Becton Dickinson (NYSE:BDX) said today it has updated two voluntary recalls of certain Alaris infusion pump modules and infusion sets used with those modules. The FDA has designated both recalls as Class I, as the agency has received reports of several serious injuries associated with the recalled devices. The Alaris model 8100 modules were manufactured […]
BD recalls SmartSite syringe administration set
Becton Dickinson (NYSE:BDX) recalled nearly 3,000 leaky SmartSite syringe administration sets used in the neonatal intensive care unit in what the FDA deemed a Class I action. Franklin Lakes, N.J.-based BD issued an urgent medical device recall in February involving 2,900 of its SmartSite syringe administration sets, which are used with infusion pumps to deliver medication, […]
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