Federal health regulators have asked H&P Industries Inc., which does business as the Triad Group of Hartland, Wisconsin, to stop making and distributing alcohol swabs and other medical products. According to a report on MSNBC, the Food & Drug Administration (FDA) made the cease and desist request after it concluded an inspection of the H&P Industries Inc. yesterday that turned up “evidence that shows this firm made and distributed products with a variety of opportunistic pathogens.”
Over the past few months, Triad Group has issued several massive<"http://www.yourlawyer.com/practice_areas/defective_medical_devices"> recalls of alcohol prep pads, alcohol swabs, and alcohol swabsticks, as well as lubricating jelly products, sold under various brand names because of potential contamination with the bacteria Bacillus cereus. Less than two weeks ago H&P Industries issued a Povidine Iodine Prep Pad recall because of concerns that they could be contaminated with Elizabethkingia meningoseptica, a type of bacteria associated with flesh eating bacteria disease, meningitis in newborn infants and pneumonia in patients on ventilators.
In February, the parents of a toddler named Triad Group in wrongful death lawsuit after their child died from acute bacterial meningitis following what was supposed to be the routine surgical removal of a benign cyst near his brain. According to the lawsuit, sterile alcohol pads made by Triad Group were used in the surgery, and the family has alleged negligence on the part of the company. Triad Group faces at least one other lawsuit over the tainted products.
In the midst of the recalls, Triad had already shut down one production line after it was found to be contaminated. While the FDA’s request that it stop producing and selling medical products marks the strongest action the agency has taken against the company thus far, it is still just a request, which H&P Industries could choose to ignore. In order to force H&P Industries to stop selling products, the FDA would have to obtain a court order, MSNBC said. The agency has not yet concluded its investigation of the H&P Industries situation or made a final determination that could lead to sanctions including court action.
H&P Industries has not said yet whether it will comply with the FDA’s request. But just days ago, H&P Industries officials vowed to overhaul its management and revamp quality control and manufacturing processes in the wake of government inspections, MSNBC said. But they made similar promises in 2009, after previous FDA inspections found issues with basic validation of the processes used to ensure sterility and stability of several Triad products, including lubricating jelly used in vaginal exams and alcohol swab sticks and pads. The fixes the company promised were supposed to be in place by June 1, 2010, just four months before a 10-year-old boy with leukemia developed a life-threatening infection caused by Bacillus cereus traced to Triad alcohol pads, MSNBC said.