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FDA 632 articles

Quaker Oats announces granola bar recall following Listeria concerns

Recall - Quaker Oats quinoa granola bars

Quaker Oats, an American food conglomerate headquartered in Chicago and owned by PepsiCo, has announced a granola bar recall upon learning certain ingredients may be contaminated by Listeria monocytogenes. If a Listeria infection were to occur, serious and sometimes fatal side effects can occur depending on the immune system of the one infected. Symptoms can include, but are not limited to: high fever, severe headache, stiffness, abdominal pain and diarrhea. Although a majority of the potentially dangerous granola bars were kept from reaching retail shelves, the following Quaker Oats products were distributed across the nation: 6.1 ounce boxes of Quaker ... Read More

Lawsuits Regarding allegedly Faulty IVC Filters are Piling Up

IVC filter

Product liability suits against Boston Scientific Corp. and Cook Medical Inc. for their IVC filters allege that the devices were faulty, resulting in patient injury. Boston Scientific’s Greenfield Filters and Cook’s Celect Filters have been linked to major issues with several women recently, leading to several lawsuits filed in Kentucky federal court. The lawsuits accuse the companies of making faulty vena cava filters that are prone to damage, tilting, or closing. An IVC filter is a cage-like device inserted into the inferior vena cava, which is supposed to catch blood clots and preventing them from traveling to the lungs and/or heart. It is often used ... Read More

As Many as Half a Million Patients at Risk from Metal-on-Metal Hip Implants

hip

The U.S. Food and Drug Administration (FDA) spent two days convening a meeting to address the issues with the metal-on-metal hip implants, and for good reason: the metal-on-metal designs, such as the ones made by DePuy Orthopaedics, a subsidiary of Johnson & Johnson; Zimmer Holdings Inc. and Wright Medical Group, have been linked to injures, muscle and tissue damage, bone damage, loosening, and more. As many as half a million recipients of the metal-on-metal hip implants could be at risk. The metal-on-metal hip implant devices were recommended for patients with a more active lifestyle, based on claims the all-metal system was a better ... Read More

FDA reports 3M Did Not Notify agency of Inefficient Bair Hugger Device Filter

Bair Hugger

According to a recent injury report filed with the FDA, 3M, the maker of the Bair Hugger warming blanket, did not notify the FDA that the filter used in the blower of the device had been reduced to only 62 percent efficiency. Per the FDA, no less than 99.97 percent efficiency is permitted. When the injury report was filed, it described a patient that had been a victim of severe infection from his hip implant surgery, following the use of a Bair Hugger warming blanket. He was required to have three additional surgeries to treat the infection, clean the area, remove dead tissue in his ... Read More

Sunflower kernel recall announced by SunOpta; potentially contaminated by Listeria monocytogenes

Recall - sunflower kermels, listeria risk

SunOpta, a food and mineral company located in Canada, has announced a sunflower kernel recall upon discovering the kernels may be contaminated by Listeria monocytogenes. From Feb. 1, 2016, through Feb. 19, 2016, the recalled sunflower kernels were produced at the company’s Cookston, Minn., facility. The food products were sold in clear printed plastic packages with Best By Dates located on either the front of back of the wrapper. The following SunOpta products, along with their various details, are included in the sunflower kernel recall:   Product Description Size UPC Lot # Best By Date Dakota’s Best Biggy’s Roasted and ... Read More

Dole now under criminal probe following packaged salad recall; four deaths, many hospitalized

Recall - Dole salad - manufacturing code

Dole Food Co., the world’s largest producer of fruits and vegetables, is now under criminal investigation by the U.S. Justice Department (DOJ) after a listeria outbreak at the beginning of this year took four innocent lives in the U.S. and Canada. While the DOJ has declined to comment on the recent probe, Dole “has recently been contacted” by the government agency regarding its recent recall of all packaged salads from its processing facility in Springfield, Ohio. Just last week Dole finally announced it had restarted limited production at the Springfield plant, which would continue to expand in the coming weeks. ... Read More

FDA Cleared Metal-on-Metal Hip Implants without Clinical Testing

metal on metal hip parts

When Consumer Reports did an investigation regarding the FDA and approved medical devices designed to be implanted into the body, what they found was disturbing to say the least. “Medical devices often aren’t tested before they come on the market,” Consumer Reports says. That was the case for the DePuy ASR XL metal-on-metal hip that has allegedly injured thousands of patients, including Stephen Tower, M.D., a 55-year-old orthopedic surgeon. About a year after receiving his hip implant, Tower could tell that something was wrong. He experienced pain from his hip “pretty much constantly”, his chromium and cobalt blood levels were through the roof, ... Read More

Reports of Injuries and Deaths Linked to Retrievable IVC Filters

IVC filter

Retrievable IVC (inferior vena cava) filters are cage-like devices that are implanted into the largest vein in the body – the inferior vena cava – and are intended to catch blood clots before they enter the heart and/or lungs. This method is intended to prevent pulmonary embolism from occurring, and is often used in patients that cannot tolerate blood thinning medication. But as patients are sustaining injuries linked to flaws in the design of the IVC filters, lawsuits are pouring in against the IVC filter makers such as C.R. Bard and Cook Medical. When Gloria Adams, age 55, had a ... Read More

C.R. Bard slapped with warning for marketing IVC filter removal device without FDA approval

IVC filter

When the U.S. Food and Drug Administration (FDA) inspected two C.R. Bard facilites, its findings were significant enough to issue a serious warning letter. Bard is a medical technology developer and manufacturer, and the maker of retrievable IVC (inferior vena cava) filters that have been linked to numerous reports of patient injuries and deaths. The letter specifically addresses the Recovery Cone Removal System, Model RC-15, which is a device designed to remove retrievable IVC filters such as the Recovery Filter, the G2X Filter, the G2 Express Filter, and the G2 Filter. However, the device was being marketed without required clearance or approval, ... Read More

FDA notifies public, Boston Scientific may have used counterfeit raw materials in surgical mesh

transvaginal mesh

The Food and Drug Administration wants health care professionals and patients to be aware that they are in the process of investigating allegations that Boston Scientific used counterfeit raw materials in its urogynecologic surgical mesh products. Additional testing is being done to determine if the mesh manufactured using the raw materials that have come under recent allegations is equivalent to the mesh originally approved by the FDA. The tests will also address the safety and effectiveness of the final product. The FDA anticipates these tests lasting several months and it will update its webpage with new information as it becomes available. It ... Read More