April 26--A Wisconsin company that makes first-aid kits used by outdoor enthusiasts is telling people to immediately destroy the Triad Group iodine prep pads in the kits because the pads could be contaminated with life-threatening bacteria and have been the subject of a national product recall.
Wisconsin Pharmacal Co., of Jackson, said the Povidone iodine pads were included in various Atwater Carey first-aid kits.
Consumers are urged to dispose of the pads but keep the rest of the kits, said Brian Meehan, a Wisconsin Pharmacal spokesman.
With the possible exception of the iodine pads, the kits are not contaminated, Meehan said.
Wisconsin Pharmacal manufactures products such as first-aid kits, water purification tablets, insect-bite relief products, hand sanitizers and lip balms. The first-aid kits are sold through specialty stores and online through outlets such as Amazon.com and CampingWorld.com.
Povidone iodine pads are used to prevent infection in minor cuts, scrapes and burns, and are an antiseptic for skin before surgery.
The Triad Group pads were made by H&P Industries, a sister of Triad Group based Hartland. The company has launched three product recalls in recent months, including all of its sterile and nonsterile alcohol wipes and swabs used in hospitals, medical clinics and households.
The alcohol pads could be contaminated with Bacillus cereus bacteria that could lead to life-threatening infections, especially in surgical and immune-suppressed patients, according to the Food and Drug Administration.
The iodine pads could be contaminated with Elizabethkingia meningoseptica bacteria, which can produce life-threatening infections that have limited treatment options, according to the FDA.
The iodine pads were sold under various names including Triad, Cardinal Health, Medical Specialties, VHA, Triad Plus, North Safety and Total Resources. They were sold in individual packets and in boxes of 100 packets, in addition to being in some medical kits.
Wisconsin Pharmacal says Atwater Carey customers should contact the company if they have the iodine pads in their first-aid kits. The kits now being produced don't have the pads, the company said.
Wisconsin Pharmacal has not decided how it will handle replacements or refunds, Meehan said.
"We're working closely with the FDA and following their specific protocol for recalls. We're also working with Triad to get information out to consumers, while addressing any concerns they may have. At this point, our primary focus is disseminating information," he said.
Triad and H&P have suspended operations pending the outcome of an FDA investigation into contamination issues at the H&P plant, which is currently closed.
Since January, the FDA has received 201 reports about Triad alcohol prep pads, including allegations of seven deaths, 114 infections and 87 minor problems such as rashes, according to MedWatch, the agency's reporting system.
A preliminary assessment shows that six of the seven deaths did not cite a specific microbial pathogen or a specific cause of death, the FDA said. A preliminary assessment of one death, of a 2-year-old Houston boy, showed that he died from acute bacterial meningitis and sepsis attributed to Bacillus cereus.
Triad faces at least three consumer lawsuits alleging its products caused sickness and death. The Houston boy's parents, Shanoop and Sandra Kothari, say in a lawsuit that an alcohol wipe made by H&P was the likely source of bacterial meningitis that killed their son, Harry, in November.
Last week, Medikmark Inc., a medical-kit company in Waukegan, Ill., filed a lawsuit alleging that Triad Group failed to ensure that its products were safe. The lawsuit sought damages but did not give a specific dollar amount.
Monday, a spokeswoman for H&P and Triad Group said company officials were consulting with the FDA and they had nothing new to report.
Previously, the companies have denied any intentional wrongdoing. H&P has said it hopes to resume production in Hartland.
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