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 […]
Medtronic’s insulin pumps highlighted in medtech injury report
A new report published this week by the International Consortium of Investigative Journalists and media organizations around the world took aim at medical device companies and the regulations that govern the $400 billion industry. And in a related report about Medtronic (NYSE:MDT), the authors zero in on the company’s diabetes unit and its insulin pumps. Over the […]
Fresenius Kabi recalls sodium chloride injections over latex concern
Fresenius Kabi USA voluntarily recalled 163 lots of sodium chloride injections last week, noting that the product contains latex despite an insert that states otherwise. The company’s recall includes 0.9% injections in 10 mL vials and 20 mL vials. The product insert and the tray label for both kinds of vials say that the products’ stoppers […]
FDA recalls heart failure, blood pressure drugs due to cancerous contaminant
The FDA announced last week a voluntary recall of several high blood pressure and heart failure medications containing valsartan due to a cancerous impurity. Some valsartan drugs were found to contain N-nitrosodimethylamine (NDMA), a compound that is classified as a probable human carcinogen. Not all drugs containing valsartan were recalled, the FDA noted. Teva Pharmaceuticals (NYSE:TEVA), […]
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