Posts Tagged ‘ Alcohol Prep Pad ’

After Alcohol Wipe Screw-Ups, Triad Decides to Play with Makeup

October 18th, 2012. By AbiK

Ok, could be makeup. Could be some anti-aging wonder. Could be your run-of-the-mill hand soap. Who knows? The initial reports regarding Triad Group’s foray into cosmetics have been a bit lacking in detail as to what exactly will be coming of the manufacturing lines at Triad’s Hartland, WI production plant.

Triad, if you recall, was at the heart of the alcohol prep pad, alcohol swab and alcohol swabstick, aka alcohol wipe recall of last year—the one connected to the death of 2-year old Harrison Kothari in Texas who contracted acute bacterial meningitis caused by Bacillus cereus bacteria. The Kotharis have settled with Triad—as have a dozen others who filed contamination lawsuits (details of the settlements have not been disclosed).

Fast-forward a year. The Milwaukee Journal Sentinel reported that Triad, which filed for bankruptcy protection on the heels of its $5 million insurance policy being drained on the lawsuits just mentioned, has indicated it would like to re-establish itself as a cosmetics company.

Every cat has nine lives, right?

The Journal Sentinel quoted Triad’s COO, Eric Haertle, as saying at the company’s first meeting with creditors in bankruptcy court, “We are in the infancy stage of these opportunities. We have talked to industry vendors. I am encouraged and optimistic about the support we are receiving if we can put a plan together and resume operations.”

What’s interesting here is not so much that Triad even wants to emerge like a phoenix from the ashes—hey, it’s a business wanting to cut its losses and get on with things—no, the interesting thing is their costume change; they’ll now wear the i.d. of “cosmetics company” rather than that of “medical device” company—and that has benefit for a company whose odds of reincarnation under their former classification are next to nothing.

See, in order for Triad to go back to being a medical device company and manufacturing as it had before, it faces some intense scrutiny by the FDA. According to the Journal Sentinel, both the FDA and Triad would need to agree to the FDA’s consent decree which would impose a $15,000 per day fine—per violation—should Triad fail to comply with FDA policies. Additionally, the decree would subject Triad to FDA inspections without prior notice–and those inspections could cover everything from equipment to raw materials to finished products to packaging. The decree also calls for the company to post a $4 million bond.

No small undertaking to set up shop again.

But, there’s an escape hatch: re-establishing itself as a cosmetics company means less rigorous regulation and oversight by the FDA. And given that the consent decree to operate as a medical device company again could cost Triad millions—with no guarantee they’ll even pass with flying colors—well, the land of lipstick bullets, lotions and potions suddenly has tremendous appeal.

On second thought, maybe there is a clue as to what cosmetics will be coming off Triad’s production line—those Triad alcohol swabsticks look a lot like those cotton swabs used to smudge eyeliner (for that smoky eye look) or to clean up little makeup mistakes…hmm…just wondering…

Tags: Alcohol Prep Pad, Alcohol Swab, bankruptcy, Cosmetics, FDA, Lawsuit, Recall, Settlement, Triad
Posted in Defective Products, Drugs/Medical, lawsuits, Settlement | No Comments »