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Second Maker of Supposedly Sterile Wipes Recalls Products for Possible Contamination

By September 22, 2011July 16th, 2019Defective Medical Device litigation

As a dangerous medical device attorney, I’ve written several posts in this space about the dangers posed by Triad products. The alcohol wipes, prep pads and other disposable items are intended to be sterile so they can be used to clean and prepare the body for injections, surgery or other actions that increases the risk of infection. Tragically, Triad’s products were not sterile; they turned out to be infected with a bacterium called Bacillus cereus. Before the problem was caught, the ensuing infections killed a little boy in Texas and caused life-threatening illnesses to at least two other people. Worse, investigation showed that the FDA had known about gross safety violations at Triad’s Wisconsin plant for quite a while, but failed to address them. So I was sobered and disappointed to see an MSNBC article suggesting that a second alcohol prep wipes company has recalled potentially infected products.
Professional Disposables International, or PDI, shares a supplier with Triad, the now-defunct Wisconsin company. PDI has recalled all lots of five of its alcohol prep pad products because of positive test results for Bacillus cereus — the same organism in the Triad pads. Both companies bought their pads from Tudor Converted Products Inc. In fact, a Triad company has claimed in litigation that the pads from Tudor were the source of the Bacillus infection, though both Tudor and a spokesperson for PDI deny this. The article did not note whether the FDA has found any problems at PDI’s New York plant. Much of the media attention on Triad focused on gross violations at its plant, including the use of products known not to be sterile, insufficient radiation for sterilization, failure to adequately clean equipment and more. To make matters worse, the FDA let these violations slide, resuming inspections only after a Colorado hospital traced infections back to Triad and notified the agency.
Perhaps the most frightening part of this story is that alcohol prep pads are used to sterilize people’s skin where wounds are or soon will be. By introducing a bacterium into that area, the un-sterile pads do the exact opposite of what they are supposed to do, putting patients at risk of developing a life-threatening infection. That’s exactly what happened to Peyton Armstrong, who was 10 years old and being treated for leukemia when he developed a life-threatening Bacillus infection. It’s also what happened to two-year-old Harrison Kothari, who died of his infection after undergoing what was supposed to be minor surgery. More than 100 others have contacted the Kothari family’s attorney — and in fact, the true number of affected people may be much higher, because the problem extends across many Triad products distributed under multiple brand names across the U.S. As a defective drug lawyer, I hope the FDA is working hard to avoid repeating this terrible experience.
At Carey, Danis & Lowe, we focus our practice on the complex, serious and avoidable injuries caused by defective drugs and medical devices. Patients use the drugs and devices their doctors give them with the belief that their health will improve. When the product is dangerous by design, or contains a major manufacturing flaw like an infection, the product can actually be responsible for making things worse. A lawsuit cannot reverse the injury or illness, unfortunately — but it can help victims deal with the results of their injuries. Our pharmaceutical liability attorneys help victims pass the financial responsibility for the injuries back to the people whose carelessness or greed caused them. Victims can claim all of their financial losses, including lost wages and medical costs, as well as compensation for permanent disability, a loss in the family or more.

If you or someone you love suffered a serious injury because of a defective or tainted medication, don’t wait to call Carey, Danis & Lowe for help. For a free, confidential consultation, send us a message online or call 1-877-678-3400.
Similar blog posts:
US Marshals Force Triad Alcohol Prep Pad Maker to Obey FDA Shutdown Order
FDA Resumed Triad Inspections Only After Colorado Hospital Found Contamination
Complaints About Contaminated Alcohol Wipes Growing After MSNBC Investigation