After several recalls, one nationwide; Bacillus cereus contamination; and links to a number of illnesses and one death, the Triad Group of Harland, Wisconsin is shutting down the line that manufactured <"http://www.yourlawyer.com/practice_areas/defective_medical_devices">tainted alcohol prep products, pads, wipes, and swabs. As weâ€™ve previously written, use of Triadâ€™s recalled, contaminated alcohol prep pads, wipes, and swabs could lead to life-threatening infections.
An internal Triad letter (dated February 25th) obtained by MSNBC said it intends to â€œmove awayâ€ from its health care division, focusing on private label and contract brands. â€œWe all need to rededicate ourselves to our customers and earn back their trust, this is an opportunity I relish,â€ wrote Eric Haertle, Triadâ€™s chief operating officer, quoted MSNBC. Haertle also wrote that the firm, family-owned for three decades, is facing â€œdifficult timesâ€ in the wake of massive recalls, lawsuits, a U.S. Food and Drug Administration (FDA) investigation, and a series of MSNBC.com reports. Haertle never admitted wrongdoing and wrote, â€œWhat has not been said is that we intend to fight any and all accusations against this company,â€ quoted MSNBC.
Parents of two children who blame Triad for their childrenâ€™sâ€™ illness say the move comes too late, saying: “We still ask: Where is the FDA? Knowing of Triad’s violations and what they have done, when will they shut down this company for good?” wrote the families of Harrison Kothari, two, who died in December from an infection blamed on Triad wipes, and Peyton Armstrong, 10, a leukemia patient who developed a life-threatening infection that hospital officials blame on Triad pads, quoted MSNBC. No sanctions have been issued against the defective device maker, although government documents indicate ongoing contamination and sterilizations at Triad since at 2009, wrote MSNBC.
Triad is stopping production of sterile lubricating jelly following a December 27, 2010 recall and links to vaginal infection reports in women prescribed the defective medication, said MSNBC. According to Haertle, the prep pads and jelly are Triadâ€™s two largest lines in the soon-to-be-shut-down division.
FDA officials said there was no â€œimminent health hazard,â€ quoted MSNBC, despite that some children at The Childrenâ€™s Hospital in Denver developed bloodstream infections as a result of Bacillus cereus, later cultured from the contaminated Triad wipes, said MSNBC noting that Peyton Armstrong was among that group. Also, in addition to the medical device litigation against Triad by Harrisonâ€™s parents, Joe Postich, 55, of Madisonville, Tennessee, filed a lawsuit following open heart surgery he was forced to undergo after he contracted Bacillus cereus infection linked to tainted wipes, said MSNBC. Peytonâ€™s parents are also in the process of filing a lawsuit.
Harrison Kothari was suffering from complications following surgical removal of a benign cyst near his brain. He died from acute bacterial meningitis, said ABC News. â€œHe was supposed to get discharged the next day,â€ said Shanoop Kothari, Harrisonâ€™s father, quoted ABC News. Harrison died on December 1st. The heard about a recall involving the same brand of sterile alcohol pads used in Harrisonâ€™s procedures, prompting them to file a lawsuit alleging gross negligence, said ABC News. 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. ABC News noted that the FDA recall was a Class 2 and not the more serious Class 1.
At Triad, investigators found contamination of water pipes leading to vats, according to the January 7th FDA Form 483, which said employees packed acne pads into containers with their bare hands; one employee neglected to include the active ingredient to a batch of childrenâ€™s multi-symptom cold medicine; Triad employees responsible for â€œmicrobial testing of finished drug productsâ€ had neither the education nor background to do their jobs; Triad was understaffed in the areas of supervision of â€œdrug product manufacture, processing, packing, and holdingâ€; and some employees could â€œnot speak, read, or write English to sign off on finished products in the warehouse,â€ said MSNBC.
The FDA has received 161 reports of adverse events related to alcohol prep wipes.