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, […]
Medtronic recalls MiniMed pump models on cybersecurity risk
Medtronic (NYSE:MDT) today recalled two models of its MiniMed insulin pumps after researchers discovered cybersecurity risks that could allow a hacker to take control of the devices. The recall affects 11 models in Fridley, Minn.-based Medtronic’s line of MiniMed 508, MiniMed Paradigm and MiniMed Paradigm Veo pumps, according to the FDA. Medtronic said the pumps […]
Alvogen recalls fentanyl patches over 3M labeling error
Alvogen announced that it is voluntarily recalling two of its Fentanyl Transdermal System 12 mcg/h transdermal patches to the consumer level because of a labeling issue. The company says that a small number of cartons that were labeled as 12 mcg/h Fentanyl Transdermal System patches actually had 50 mcg/h patches. The 50 mcg/h patches in […]
FDA: West Pharma recall of Vial2Bag fluid transfer systems is Class I
The FDA recently labeled a select recall of West Pharmaceutical Services‘ (NYSE:WST) Vial2Bag fluid transfer systems over device functionality issues as Class I. Class I designations, the FDA’s most severe, are used when there is a reasonable probability that product use could cause serious adverse health consequences of death. The West Whiteland Township, Penn.-based company’s Vial2Bag […]
Results RNA recalls eye drops over undeclared colloidal silver
Results RNA said this week that it voluntarily recalled its Lubrisine eye drops following an FDA inspection that found the product was not manufactured with sterile practices. The company also said that the eye drops, which are designed to lubricate dry eyes, were found to contain undeclared colloidal silver. Exposure to colloidal silver over an […]
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