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In January, the Triad Group of Wisconsin, a manufacturer of medical product,s issued a recall of tens of millions of sterilizing pads, wipes and swabs due to potential contamination with the bacteria Bacillus cereus. The products subject to the recall are manufactured by the “Triad Group” and sold under labels including Boca/Ultilet, VersaPro, Cardinal Health, CVS, Conzellin, Moore Medical, PSS Select and Walgreens.

A number of contaminated Triad product lawsuits have emerged in the wake of the Triad Group recall, including one relating to the death of a two-year old child who allegedly contracted the bacteria after using Triad Group alcohol wipes. Since the recall, dozens of others have come forward as well with issues related to the contaminated swabs. However, even prior to the recall in January, the FDA allegedly had information that raised concerns related to potential contamination of the sterilization products. Specifically, in both 2009 and 2010 during inspection visits to Triad Group manufacturing plants, FDA inspectors were unable to validate the processes used to ensure quality and sterility, among several other issues related to quality control. The Triad Group itself also seems to have had in its possession information that infections and other medical issues had arisen after the use of its products.

The use of contaminated Triad Group’s contaminated products—Alcohol Prep Pads, Alcohol Swabs, or Alcohol Swabsticks—could lead to life-threatening infections, particularly for at risk populations including immune suppressed and surgical patients. To contribute to FDA monitoring and investigating efforts, any individual who has used a Triad Group product and experience an adverse reaction, such as a skin rash, can file a report with the FDA at a website set up specifically for this purpose.

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