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The U.S. Food and Drug Administration announced earlier this month that it has notified healthcare professionals of a Class I recall of the GE Healthcare Vital Signs Hygroscopic Condenser Humidifier Passive Humidification Device for Vital Signs Anesthesia Breathing Circuits. The Class I recall, the FDA’s most serious, confirms the concerns the FDA has about the product, which is sold as a part of the Vital Signs anesthesia breathing circuit and is used to maintain moisture in the patient’s airway during…

Medications that control epilepsy, such as Depakote, Depakene and Depakon may affect a fetus if used during pregnancy, the U.S. Food & Drug Administration reportedly said recently. From that announcement, the FDA reportedly said it will be changing the labels of all these types of drugs, called valproate drugs, which are used to treat epilepsy and some manic symptoms associated with bipolar disorder. The FDA reportedly said that children of women who took the medications during pregnancy have an increased…

The medical device company Beckman Coulter, Inc., issued a recall in May for their Synchron LX Ion Selective Electrolyte Flow Cell, which is classified by the FDA as a Class I recall by the U.S. Food and Drug Administration, say reports. Reports say the pump may wear incorrectly, causing silver iodide build-up and microbial contamination and, ultimately, incorrect electrolyte delivery, which can eventually cause adverse health consequences. The components are are chemical analyzers that are computer-controlled which analyze blood, urine…

The oft-maligned DePuy hip implant device, which was recalled last summer, has been cited in a lawsuit by 20 Australians earlier this month. The suit claims the device, which is surgically implanted in the hip socket, eventually necessitates the need for a painful and complicated second surgery. In addition, reports say, there are illnesses linked to metal toxicity from the components, such as concerns of severe tissue and bone damage as well as metal infiltrating the bloodstream. The federal class…

Reports say a defective fan may become overheated and shut down the Maquet Datascope Intra-Aortic Balloon Catheter Pump without sounding any warning alarm, and ultimately injuring patients. Due to that possibility, Maquet Datascope Corporation notified customers that representatives would replace power supplies on affected devices. The Class I recall – the most serious type of recall as judged by the FDA — involves some models of Intra-Aortic Balloon Pumps manufactured between 2008 and 2010. For the exact specifications of pumps,…