<“https://www.yourlawyer.com/practice_areas/defective_medical_devices”>Tainted alcohol swabs made by Triad group are being named in medical device litigation concerning the wrongful death of a toddler. As we reported previously, the products were involved in a medical device recall of contaminated alcohol prep pads, alcohol swabs, and alcohol swabsticks manufactured by Triad Group because concerns with Bacillus cereus containation.
As weâ€™ve mentioned, use of any of these defective redical devices could lead to life-threatening infections, especially in at-risk populations, such as the immune suppressed and surgical patients.
In this case, two-year-old Harrison Kothari, who was suffering from complications following surgical removal of a benign cyst near his brain, died from acute bacterial meningitis, said ABC News. “He was supposed to get discharged the next day,” said Shanoop Kothari, Harrison’s father, quoted ABC News. Harrison died on December 1st. “Nobody from the hospital could tell us how he got this rare bacteria, what caused it, it was a mystery,” added Mr. Kothari.
The family then heard about a recall involving the same brand of sterile alcohol pads used in Harrisonâ€™s procedures, prompting them to file a lawsuit against the Triad Group, alleging gross negligence, said ABC News. The lawsuit was filed yesterday against the largest maker of sterile pads.
The lawsuit sites the urgent, voluntary recall on January 3rd over â€œpotential contaminationâ€ with an â€œobjectionable organism,â€ quoted ABC News. The potentially deadly organism cited is Bacillus cereus, which can cause meningitis, the infection that killed Harrison, explained ABC News. According to Triad Groupâ€™s website, “There has been one report of a potential contaminant out of hundreds of millions of products sold,” reported ABC News.
The familyâ€™s attorney alleges that the bacteria that killed the boy is known and it is the same bacteria known to be on the recalled pads, noted ABC News; however, there is no direct evidence linking the swabs used in Harrisonâ€™s procedure to a contaminates swab.
According to the U.S. Food and Drug Administration (FDA), the Triad Group followed recall steps correctly by notifying the FDA and issuing a voluntary recall, it said; FDA issued its own recall notice on the matter, noting that the recalled pads are widely sold under other names. “They could be potentially in everybody’s home, in their bathroom, they have no idea. I wanna make sure that this doesn’t happen to anybody else,” said Sandra Kothari, quoted ABC News.
The original recall notice, as weâ€™ve written, involved Alcohol Prep Pads, Alcohol Swabs and Alcohol Swabsticks used to disinfect skin prior to an injection and can be identified by â€œTriad Group,â€ listed as the manufacturer; the products are also manufactured for a third party and use the following names in the packaging: Cardinal Health, PSS Select, VersaPro, Boca/Ultilet, Moore Medical, Walgreens, CVS, Conzellin. The Medical Device Recall affects products marked as STERILE as well as non-sterile products.
Some drug makers issued their own warnings, such as Pfizer Inc.; Merck & Co.; Progenics Pharmaceuticals Inc, a partner of Pfizer, GlaxoSmithKline PLC; Roche Holding AG; Bayer AG; Teva Pharmaceutical Industries Ltd. because, although their medications were not contaminated, the Triad pads, swabs, or swabsticks included in the medicationsâ€™ packagingâ€”for an array of different medicationsâ€”were part of the recall.
ABC News noted that the FDA recall was a Class 2 and not the more serious Class 1.