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FDA 612 articles

Cybersecurity in medical devices: FDA addresses device manufacturers in updated guidance

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As more cybersecurity concerns continue to threaten our country, the U.S. Food and Drug Administration (FDA) has updated its guidance on how medical device makers can ensure their approved products are safe from cyberattacks and report any post-approval fixes. According to Law360, the FDA’s announcement adds to a prior document highlighting the dangers associated with medical device software. The agency also held a public workshop Jan. 20-21 at its Silver Spring, Md., campus to discuss how different sectors can work together and reduce risks with Internet-connected medical devices. The FDA is emphasizing the importance of post-approval vigilance due to the growing tactics used by ... Read More

Trader Joe’s announces cashew recall due to Salmonella concerns

Trader Joes - wikimedia commons

Popular specialty foods chain Trader Joe’s has announced a recall of its raw cashew pieces due to the potential presence of Salmonella within one of its shipped lots. Although no other lots of raw cashew pieces tested positive for Salmonella by the FDA’s contract laboratory, Trader Joe’s opted to recall all lots of the cashews in order to ensure the safety of its customers. The cashew recall impacts all of Trader Joe’s 16-ounce non-resealable bags marked with date code labels reading, “BEST BEFORE 07.17.2016TF4.” Store locations in the following states received the potentially affected cashew pieces:  Connecticut, Delaware, Georgia, Idaho, ... Read More

Jurors, health experts agree; pharmaceutical companies held accountable for transvaginal mesh injuries

transvaginal mesh

Two weeks before the FDA reclassified transvaginal mesh as a high-risk device and issued orders that manufacturers submit a rigorous premarket approval application addressing safety concerns, on Dec. 22, 2015, Philadelphia jurors were reaching a verdict on the first case to be tried in Philadelphia’s mass tort program over pelvic mesh products. Their decision was right in line with the medical news that was soon to follow. Jurors awarded Indiana woman Patricia Hammond, 65, a total of $12.5 million in her lawsuit against Johnson and Johnson and its division, Ethicon. Of that amount, $5.5 million was awarded in compensation for damages ... Read More

How will the FDA ruling impact TVM litigation?

transvaginal mesh

The U.S. Food and Drug Administration’s (FDA) two orders issued this week, reclassifying transvaginal mesh (TVM) as a high-risk device for treating Pelvic Organ Prolapse (POP) and ordering manufacturers to submit a rigorous premarket approval (PMA) application demonstrating safety and effectiveness within the next 30 months, are, according to the agency’s press announcement, based on thousands of reports of adverse events related to mesh used for urogynecological procedures in the past several years. “The FDA ruling confirms what we have been seeing from Plaintiffs in this litigation – transvaginal mesh used to treat pelvic organ prolapse is responsible for serious, chronic injuries for ... Read More

Sweet Leaf Tea recall announced after glass fragments found; 1.5 million bottles recalled

Recall - Sweet Leaf Tea

After reports of glass fragments being discovered within the product, Sweet Leaf Tea Co. of Nestlé Waters North America has announced a recall of nearly 1.5 million bottles of flavored iced tea out of an “abundance of caution.” From Feb. 27 through Dec. 6, 2015, the Sweet Leaf Tea was sold in 16-ounce glass bottles nationwide in the following six flavors: raspberry, half and half lemonade tea, original, green tea with citrus, peach and mint, and honey. The Sweet Leaf Tea sold in plastic bottles is not included in this recall. Jane Lazgin, Sweet Leaf Tea spokeswoman, told ABC News that while no ... Read More

FDA announces frozen corn recall after it tests positive for Listeria monocytogenes

Recall - frozen corn, FDA image

According to the Food and Drug Administration (FDA)’s recent press release, Bonduelle USA Inc. has announced a frozen corn recall, which affects more than 9,300 cases of the frozen corn due to the possibility of Listeria monocytogenes. If Listeria is present in the frozen corn, serious infections may occur in those with weakened immune systems, such as children or elderly people. If a healthy person ingests Listeria, the individual may experience short-term symptoms including high fever, headache, nausea, diarrhea, abdominal pain and stiffness. Pregnant women with a Listeria infection could have a miscarriage or stillbirth as a result of the ... Read More

Kroger recalls seasonings for possible salmonella contamination

Recall - Kroger products - image courtesy WRIC and WVEC

Popular supermarket chain Kroger has announced a sizable recall of four Kroger-brand seasonings sold in its stores. The Kroger recall was sparked by the FDA’s discovery of Salmonella in a sample of the Kroger-brand Garlic Powder sold by a South Carolina store. According to the supermarket’s press release, the following Kroger-brand seasonings were produced in the same facility with the same equipment as the Salmonella-tainted Garlic Powder and are now under recall: Kroger Bac’n Buds: 12 oz containers (Sell by: May 20 18PS4) Kroger Coarse Ground Black Pepper: 17.1 oz containers (Sell by: May 18 18PS4, Sell by: May 19 ... Read More

E-cigarette use soars among U.S. youth

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E-cigarette use tripled among middle and high school students from 2013 to 2014, the U.S. Centers for Disease Control and Prevention (CDC) and the Food and Drug Administration (FDA) reported after conducting its latest National Youth Tobacco Survey. The soaring popularity of e-cigarettes among U.S. youth has alarmed federal health authorities, who warn that nicotine poses special dangers for children and teens in no matter what form it is ingested. “We want parents to know that nicotine is dangerous for kids at any age, whether it’s an e-cigarette, hookah, cigarette or cigar,” said CDC Director Dr. Tom Frieden. “Adolescence is ... Read More

FDA files suit against Wholesome Soy after listeria outbreak kills two

Wholesome Soy Products logo

Wholesome Soy Products Inc. is now being sued by the U.S. government following a listeria outbreak traced to the company’s soybean and mung bean sprouts. According to the FDA, five people from Michigan and Illinois were hospitalized from June through August due to listeriosis – a sickness caused by the ingestion of Listeria monocytogenes. Despite receiving treatment, two of five infected individuals died as a result of the sickness. The FDA’s investigation found the listeria strains to be “highly related” to the strains discovered at Wholesome Soy’s facilities, which were cited for multiple health violations during its prior inspections. “FDA ... Read More

Aurora Products announces walnut recall spanning 21 different labels

Recall - walnuts, Aurora Products

Aurora Products, a natural specialty food producer based in Connecticut, has announced a significant recall of certain walnut and trail mix products following the discovery of salmonella during routine testing. Once the FDA was contacted regarding the finding, Aurora opted to initiate the voluntary walnut recall to remove any potentially affected containers from stores, including those with private labels. Although individuals with a strong immune systems will not experience any life-threatening ailments as a result of consuming salmonella-laden foods, consumers may experience symptoms such as nausea, vomiting, diarrhea (sometimes bloody), abdominal pain and fever. Salmonella in those with a weakened immune system, ... Read More