“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 ...
As Heartware Recalls Continue, Patients Cope with the Time Bomb in Their Chests
Posted December 3, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
As Infant Formula Crisis Continues, Confusion Emerges Over Timelines
Posted June 28, 2022 in Product News and Recalls
Congressional testimony related to the infant formula shortage that has some parents wondering where their child’s next meal may come from exposed confusion and a lack of coordination between Abbott Labs – the company responsible for making the formula – and the Food and Drug Administration. While the two successfully collaborated last month to release a limited amount of infant formula from the facility in ...
Limited Release of Baby Formula Seeks to Ease Pressure on Parents
Posted June 3, 2022 in Product News and Recalls
Abbott Labs and the Food and Drug Administration plan to authorize the release of a limited quantity of baby formula to ease demand. The move comes as empty shelves are increasingly pushing parents to panic over where their infant’s next meal may come from.
Stocks have run low for months after multiple cases of bacterial contamination led to multiple infant hospitalizations and at least ...
continue reading...Philips Threatened with Massive Refunds as FDA Grows Impatient Over Respiratory Devices
Posted May 31, 2022 in Drug and Medical Device Lawsuits | Product News and Recalls
The FDA is not happy with the pace of Philips’ response to an issue with multiple lines of respiratory devices. The corporation recalled millions of the devices almost a year ago and has yet to provide customers at home and at hospitals with a plan to replace the machines that, according to the recall, could be sending carcinogenic foam particles into their lungs and increasing their ...
FDA Comes Up Short as Feds Continue Investigation into Tainted Baby Formula
Posted May 10, 2022 in Product News and Recalls
As shortages worsen across the nation, a federal investigation into the source of tainted infant formula has so far yielded no definitive match to an Abbott Labs production facility in Sturgis, Michigan. The facility was responsible for the production of some of the most trusted and well-known brands of infant formula in the country including Similac, Elecare, and Alimentum.
The Abbott Labs facility ...
continue reading...Citing a need for improvement in the way Philips has handled its duty to notify patients of the recall of a variety of its ventilators and breathing aids, the FDA issued an order to the corporation earlier this month mandating a more open flow of information.
In a statement on the agency’s website, the director of its Center for Devices and Radiological Health acknowledged ...
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