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Fujifilm issues urgent notice regarding duodenoscopes

duodenoscope

Fujifilm issued an Urgent Medical Device Correction and Removal notification regarding its specialized endoscope used to diagnose and treat specific conditions of the gastrointestinal tract. The recall of all of its ED-530XT duodenoscopes involves the replacement of the ED-530XT forceps elevator mechanism including the O-ring seal, replacement of the distal end cap, and new Operation Manuals. The Food and Drug Administration (FDA) cleared the updated design and labeling of the device last week. As noted in the FDA’s February 2015 Safety Communication, the complex design of duodenoscopes may impede effective reprocessing, a detailed, multistep process to clean and disinfect or ... Read More

Monsanto Dicamba Allegedly Causing Crop Damage

farm-laborers

Dicamba, an herbicide developed by Monsanto for use on crops genetically engineered to resist it, has become the target of a growing number of complaints from farmers across southern Minnesota. According to Minnesota Public Radio News, the Minnesota Department of Agriculture is currently investigating about two dozen complaints from farmers in the state who say that dicamba drifting from neighboring fields is harming their crops. Farmers who don’t use dicamba on their crops say the drifting herbicide is deforming their soybean plants so that the leaves are severely cupped. One farmer told MPR News that the plants will grow out ... Read More

Fired Hartford Whistleblowers will be Compensated

whistleblower retaliation

Three whistleblowers are finally getting some relief after federal authorities determined they were wrongfully terminated from a Hartford, Connecticut, health care facility in retaliation for addressing serious public health concerns. Charter Oak Health Center, which provides health care services to underserved communities in the Hartford area, and its former CEO agreed to settle a complaint initiated in early 2012, when the whistleblowers turned to the Occupational Safety and Health Administration (OSHA) for help. According to OSHA, Charter Oak’s interim senior vice-president for operations, director of nursing, and coordinator of its Healthy Start program actively tried or helped with efforts to ... Read More

California Man Joins Bard IVC Filter MDL

IVC filter

A man from California has joined the multidistrict litigation (MDL) involving claims related to IVC filters. The man’s lawsuit claims his IVC filter made by Bard failed, resulting in injury. Clarence M. was given a G2 retrievable inferior vena cava (IVC) filter made by C.R. Bard to help prevent any potential blood clots from traveling to his lungs, which would result in a deadly pulmonary embolism (PE). According to The Daily Hornet, the G2 IVC Filter was surgically placed in Clarence’s vena cava vein May 8, 2010, at a California hospital. Clarence’s lawsuit claims the device maker downplayed the risks of the G2 IVC ... Read More

2,000 5-point Camlock Harness Belts Recalled

Recall - harness, seat belt, seat harness, Corbeau

Corbeau USA, LLC (Corbeau), based in Bluffdale, Utah, has recalled approximately 2,000 5-Point Camlock Harness Belts because of a defect that may lead to fall and projectile hazards, the U.S. Consumer Product Safety Commission (CPSC) reports. The belts are designed to be used as aftermarket safety devices in off-highway vehicles. The company’s website recall page explains that a defect in the right lap insert “could potentially cause the right lap belt to come unlocked from the camlock dial” with little pressure. The insert tab’s hole was drilled off center and prevents the camlock dial from locking properly. The harness belts ... Read More

Ohio Superfund site subject of EPA inquiry

Benzene

The U.S. Environmental Protection Agency (EPA) has demanded updated information on the Cardington Road Landfill, a Superfund site, to check the pollution status. The landfill, located in Moraine, Ohio, has been closed and covered since about 1980. The contamination, however, has been an ongoing concern. For this reason, the EPA is now conducting its fourth five-year review on the landfill’s conditions, WHIO.com reports. The Cardington Road Landfill is a 36-acre site that made the National Priorities List in 1986. According to the EPA website, the most concerning contaminates include benzene, trichloroethylene, toluene, xylenes, and many other volatile organic compounds (VOCs) that are ... Read More

Teething Toy Recalled Over Potential Choking Danger

Recall - toy, activity toy, Manhattan Toy

An infant teething and activity toy has been recalled because a defect creates a potential risk of choking, the U.S. Consumer Product Safety Commission (CPSC) reports. The toy’s maker, Minneapolis, Minnesota-based Manhattan Toy has recalled approximately 14,400 Winkel Colorburst teething and activity toys in the U.S. and approximately 1,000 that were sold in Canada. The toy has brightly colored plastic tubes that are inserted into a plastic cube containing rattle beads. The tubes can become brittle and break into small pieces, creating a choking danger for infants. The company confirms it has received four reports of the plastic tubes breaking, ... Read More

Idaho Man Files Lawsuit Over Cook IVC Filter

IVC filter

An Idaho man has filed a lawsuit against Cook Medical over an IVC filter that he claims is defective and led to his injuries. Jacob B. was implanted with a retrievable Celect inferior vena cava (IVC) filter on April 27, 2010, at Kootenai Medical Center in Coeur D’ Alene, Idaho. Dr. Nicole Burbank inserted the filter to catch blood clots in his bloodstream, preventing a potential pulmonary embolism (PE). According to The Daily Hornet, the Celect filter has an extremely high rate of vein perforation, more so than other IVC filters available. The Celect has been accused of defective design as far back ... Read More

Missouri talc trial rescheduled for October 16

talc justice

The National Law Journal reveals details from a newly available transcript from St. Louis Civil Court. Last month another closely watched talc trial against Johnson and Johnson was underway, following four attention-grabbing plaintiff wins totaling more than $300 million and one defense win in the previous year and a half. The sixth Missouri talc trial started on June 5, but on June 19 was declared a mistrial when the U.S. Supreme Court ruled in Bristol-Myers Squibb Co. v. Superior Court. The significant decision about jurisdiction overruled the California Supreme Court’s previous decision to allow hundreds of out-of-state plaintiffs to sue ... Read More

Drug withdrawal effects under-reported

opioid, oxycodone - Shutterstock

The severity, duration and likelihood of withdrawal effects of medications – particularly antidepressants and a large group of pain and anti-anxiety drugs – is underestimated in prescribing information for physicians and Medication Guides for patients, according to the annual report, Quarterwatch, from the Institute for Safe Medication Practices (ISMP). “In other cases, withdrawal effects were too poorly studied to support adequate estimates of injury rates,” the report adds. ISMP analyzed more than 4,000 reports of drug withdrawal in 2016 and identified 42 medications with clear signals for withdrawal effects. “Neuroscience reveals that the chemical intrusion of psychoactive drugs into complex, ... Read More