On December 1st, 2010, two-year old Harrison Kothari died from a rare infection while in the hospital recovering from surgery. As if this weren’t bad enough, the kicker is the very real possibility that the infection, acute bacterial meningitis caused by Bacillus cereus, and his subsequent death could have been prevented. So Harrison’s parents are suing the makers of Triad Alcohol Prep Pads, which the hospital used on their son in late 2010, but which were subsequently recalled on January 5th 2011 due to contamination with Bacillus cereus.
While hospitals are infamous incubators of a host of bacterial illnesses, acute bacterial meningitis is not one of them. Rather, Bacillus cereus is typically found in rare food poisoning outbreaks. Hospital officials were at a loss to explain how Harrison had contracted the infection. “They had no explanation as to how he contracted it,” Sandra Kothari, 37, Harrison’s mother told msnbc.com. “They know it’s rare in the hospital.”
Then, in January, a relative caught sight of the recall notice for the alcohol wipes and swabs on the US Food and Drug Administration (FDA) website, which reads:
“Triad Group, a manufacturer of over-the-counter products and FDA notified healthcare professionals and patients of the recall involving all lots of alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad but sold as private labels at the consumer level. This recall has been initiated due to concerns about potential contamination of the products with Bacillus cereus. This recall involves those products marked as STERILE as well as non-sterile products. Use of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks could lead to life-threatening infections, especially in at-risk populations, including immune suppressed and surgical patients.”
“These wipes were used in his [Harrison’s] care every single day, multiple times a day,” Harrison’s father, 38-year old Shanoop Kothari, told msnbc.com. And officials at the hospital have confirmed that those alcohol prep products were supplied by Triad.
“We’re confident that that’s the cause,” said Kothari. “There was no other explanation that made any sort of sense. He contracted a very rare bacteria. These swatches were tainted with that bacteria.”
This week lawyers representing the Kotharis filed a complaint in U.S. District Court in Houston, charging the Triad Group with gross negligence and seeking damages for the loss of Harrison’s life.
“Our emotional response over this has been horrible,” said Shanoop Kothari said of his family, which also includes Harrison’s 7-year-old sister, Hannah. “We’ve been devastated. We’ve been absolutely crushed.”
This tragic situation brings to light a larger problem: according to FDA spokesperson, Christopher Kelly, who spoke with msnbc.com about this matter, Triad, a 35-year old family run company, “did everything correctly” in notifying government authorities about the recall. The recalled products are reportedly also sold under private labels in Canada and Europe, as well as the US. So what does this mean for you and me—woe betide us if we do not regularly monitor the FDA website?
Understandably, Sandra Kothari is worried that others may have been injured, infected or killed as a result of exposure to these products. “I wouldn’t want any other mother to go what I’ve gone through,” she told msnbc. And it’s possible. To be clear, these wipes and swabs were widely used in hospitals and, “sold in stores including CVS and Walgreens. “People buy alcohol pads and they last a long time in your bathroom. They’re sitting there now,” she said.
The recall notice states the following:
“The affected Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks can be identified by either “Triad Group,” listed as the manufacturer, or the products are manufactured for a third party and use the names listed below in their packaging: Cardinal Health, PSS Select, VersaPro, Boca/ Ultilet, Moore Medical, Walgreens, CVS, Conzellin.
A final caveat—in case you’re wondering whether Harrison had received his bacterial meningitis vaccine—the answer is no—he wasn’t quite old enough at the time he underwent surgery. And even if he had had the vaccine, it doesn’t protect against that strain of the bacteria.
Read the Triad alcohol swab recall notice here.
All products made at Triad are subpotent and contaminated. The swabs are sold under BD name too.
All products prior to gamma sterilization fail micro tests. The left over jel in the mixing vessle is not discarded.
Enema (sold under Walgreen brand), Hemmrhoid pads, PVP swabs are contaminated. Company QC director adds bleach to enema so it passes micro test.
The machines and company is very dirty filthy.
Management is fully aware of the problems and the practice for years.
I am 79 years old and had been using the Triad wipes for an ongoing urinary tract infection for the past 7 months. many antiobiotics taken. I was getting infected by the wipes and did not know it until the hospital told me they had been recalled.I think twe victims should file a class action against Triad abd the FDA.