Posts Tagged 'FDA'

As Heartware Recalls Continue, Patients Cope with the Time Bomb in Their Chests

heartware recalls continue“It sounded like a cement mixer.” This is how one Medtronic HeartWare HVAD patient described the sound coming from deep within his chest after the device became clogged with a blood clot. Years after the initial recall was ordered under a Class I status by the FDA, thousands of patients across the country are faced with a life-threatening dilemma: do they keep the device and hope it doesn’t fail them or do they ...

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FDA Warns Against Use of Baby Neck Floats

FDA warns against use of neck floats for infantsAs temperatures climbed and families headed to the pool, the Food and Drug Administration warned parents and caregivers against the use of neck floats for infants this past summer; particularly those with special needs.

Neck floats were designed as a way of letting infants float in water without having to know how to actually stay afloat. Marketed as both flotation devices as well as water-therapy ...

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Philips Respiratory Devices Facing Additional Recalls

Philips respirators facing additional recallsAmid a recall that has already drawn the ire of federal regulators over the glacial pace with which it has handled remediation of the matter, Philips is facing an additional recall of some of its respiratory devices over an unrelated fault.

According to Reuters, the latest recall action targets 1,700 Philips respiratory devices around the world, with 386 of them located in the United States. The recall was issued ...

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Titanium Dioxide Takes Center Stage as Skittles Candymaker Sued

skittles maker sued over titanium dioxide contentIf you’ve ever eaten something that looked a little shinier than it normally should have as it came out of its packaging, then odds are you’ve consumed titanium dioxide. Added to food since its approval by the FDA in 1966, the compound is used to brighten more than just food. “It’s sort of ironic…that the ingredient in paint that makes your kitchen shiny also makes your Hostess ...

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The HeartWare HVAD System is Under a Class I Recall…Again

Medtronic heartware system again under Class I recallThe FDA recently announced that the HeartWare HVAD system was being recalled by medical device manufacturer MedTronic over concerns of battery failure. The recall marks the second time the device has been recalled, with both occurrences falling under Class I status. The Class I recall is the FDA’s most severe recall classification and is reserved for instances where the continued use of the recalled item ...

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FDA Includes Juul in Vape Ban, Granted Stay by DC Circuit Appeals Court

FDA bans Juul vapes and podsThe FDA issued its long-awaited decision regarding Juul vape devices and pods earlier this week and included the controversial devices in its sweeping bans of electronic nicotine delivery systems. Citing “insufficient and conflicting” data in the company’s application to continue selling products, the order includes the sale and marketing of its vape devices as well as its remaining tobacco- and menthol-flavored liquids. The company made the voluntary ...

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