Michael Stravato

Sandra and Shanoop Kothari of Houston, Texas, are shown last year holding a photo of their children Hanna and Harrison. Harry died on Dec. 1, 2010 at the age of 2.

The parents of a toddler who died after contracting a rare bacterial infection blamed on contaminated medical wipes have settled their lawsuit against the Wisconsin firms that made them.

Sandra Kothari, 38, of Houston, declined to release details of the financial arrangement reached with the Triad Group and H&P Industries Inc. of Hartland, Wis.

But the mother of 2-year-old Harrison Kothari said she and her husband “reluctantly” sought to settle the case instead of bringing it to trial on the advice of lawyers.

Court records filed Friday confirmed the action.

“Personally, for me, it’s not because I didn’t want to do it,” she said, adding: “It was never about the money.”

The Kotharis sued H&P and the Triad Group in February 2011 after a massive recall of medical prep wipes potentially contaminated with a rare bacterium, Bacillus cereus. They said the wipes led to an infection with the same germ that killed their son.

An msnbc.com investigation showed that federal Food and Drug Administration officials had detected problems with sterilization and contamination for years at the sister firms in Wisconsin, yet had taken no action to stop them.

Additional recalls of other products because of threats of bacterial contamination and the seizure of more than $6 million in medical products and supplies eventually shuttered the Wisconsin firms, which have yet to reopen.

Representatives from H&P and the Triad Group did not immediately respond to requests for comment about the settlement. Company officials have consistently said that there was no conclusive proof that their medical wipes and swabs caused any illness, injury or death.

Sandra Kothari said the expense and stress of a trial would not have accomplished her goal, which was to ensure the company didn’t continue to distribute tainted wipes and to pressure the government for better oversight.

“I wanted [H&P] to be penalized, and I guess, in a way, they have been,” she said.

At least 10 lawsuits nationwide have alleged that tainted H&P and Triad products have caused serious infections, illnesses or deaths. It wasn’t immediately clear if other suits would be dismissed as well.

A second firm, Pacific Disposables Inc. of Orangeburg, N.J., recalled 300 million individual prep pads last fall because of potential contamination with the same kind of bacteria cited in Harry Kothari's death.

Related:

Tracking tainted wipes: an msnbc.com special investigation

Truckloads of medical products, tankers of bulk liquids and cartons of chemicals have been hauled to secure landfills and waste disposal centers as a Wisconsin supplier works to recover from a year-long contamination scandal blamed for illness and death.

By one account, H&P Industries and the Triad Group of Hartland, Wis., had enough potentially tainted medical prep wipes to fill a football field.

The sister firms have either destroyed or reconditioned more than $6 million of suspect products seized by federal regulators last spring, bringing them in compliance with a court order, new government documents show.

The firm’s $4 million penal bond has been canceled and the seized products have been returned to H&P’s jurisdiction for disposal, possible steps toward reopening, according to new Food and Drug Administration documents obtained through an msnbc.com open records request and appeal.

The discarded products included 50 truckloads of finished goods, 13 truckloads of raw chemicals and five bulk tank-trailers of in-process materials, according to Shelly Burgess, an FDA spokeswoman.

"The firm will not be permitted to resume operations until FDA is satisfied that it can do so with full compliance with the decree and the law," Burgess said.

It took H&P Industries three tries to gain FDA approval of a reconditioning plan that outlines an overhaul of manufacturing, monitoring, inspection and reporting procedures to correct problems with contamination and sterilization. Previous plans were not detailed enough to satisfy FDA’s concerns, the documents posted online late Tuesday showed.

“Because of both micro- and cross-contamination concerns, FDA has no [good manufacturing process] assurance and is uncomfortable with introducing any potential risk back into the market,” said Tamara Ely, an FDA compliance officer, according to an account of a November 21, 2011 meeting.

Only unopened, factory-sealed raw chemicals will be allowed to be “reconditioned” so that they’re safe for use either by H&P Industries or by a vendor who agrees to accept returned product, the documents showed. The reconditioning procedure requires sampling, testing and approval to verify that no microbial contamination exists.

Everything else — finished products, in-process products, materials in tanks and drums, raw chemicals, bulk chemicals and other open, used components  — was destroyed. The firm is still prohibited from manufacturing drugs or devices, Burgess noted.

H&P’s compliance comes more than a year after FDA officials urged the company to issue the first of several global recalls of alcohol and iodine prep products potentially contaminated with at least two kinds of bacteria because of inadequate manufacturing and sterilization procedures.

FDA officials had known for years about problems with the Wisconsin plant, but had failed to adequately enforce regulations, an msnbc.com investigation found.

The move also comes nearly a year after parents of a 2-year-old Houston boy first filed a lawsuit claiming that contaminated alcohol pads made by H&P Industries were responsible for the bacterial infection that killed their son.

Since then, at least a dozen lawsuits have been filed by patients and their families in several states who claim that tainted prep wipes led to infections, illnesses and, in some cases, deaths.

H&P Industries officials did not respond to msnbc.com requests for comment, but the firm consistently has denied that its products could be directly tied to those events.

Burgess, the FDA spokeswoman, confirmed the number of truckloads of finished medical products, tanker trucks of bulk liquids and containers of chemicals that the company was forced to destroy.

But by another estimate, the volume of returned alcohol and iodine prep products alone would have filled an area “the size of a football field,” according to a lawyer representing the Triad Group.

“There are billions of these pads produced a year, millions in a day, believe it or not, so it is massive what has been returned,” lawyer Alana Bassin told U.S. District Court Judge Lynn Hughes during a July briefing, a court transcript shows.

The medical products have been transferred to secure landfill and destruction sites that operate under regulatory jurisdiction. Some of the material may have to be processed as hazardous waste, the documents noted.

H&P Industries' plans for the future remain unclear. The firm’s 285,000-square-foot plant at 700 W. North Shore Drive , Hartland, Wis., is for sale for $14.2 million, real estate listings show.

Related: Tracking tainted wipes: an msnbc.com special investigation

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The industrial plant that houses the Triad Group of Hartland, Wis., is for sale for $14.2 million, real estate listings show. The company was closed after problems with contamination and sterility in medical wipes and other products.

Federal health officials have given a green light for a first step toward reopening for a Wisconsin business shut down after making and distributing contaminated medical wipes blamed for illnesses and deaths nationwide.

Food and Drug Administration officials on Wednesday said they’ve approved a so-called “reconditioning plan” submitted by H&P Industries and the Triad Group of Hartland, Wis. The plan, required under terms of a June court order, stipulates how the sister firms will be allowed to rework more than $6 million of seized medical supplies so that they’re safe for use -- or destroy products that can’t be repaired.

But the public won’t be allowed to know exactly how the firms intend to fix the problems with products distributed to hospitals, clinics, stores and homes in the U.S. and around the world, the FDA has ruled.

The agency has denied an msnbc.com public records request for copies of two reconditioning plans submitted by the firms. In a letter, officials said release of the documents would disclose trade secrets and confidential commercial information and could interfere with law enforcement proceedings.

The approval of the reconditioning proposal comes a year this month after the death of a 2-year-old Houston boy, Harrison Kothari, from an infection caused by the same bacterium detected in alcohol prep wipes made and distributed by H&P Industries and the Triad Group.  At least 11 deaths, including Harry’s, have been tied to alcohol prep wipes, including those made by the Wisconsin firms, FDA records show.

The plan approval also comes nearly a year since those firms launched a global recall of tens of millions of wipes, swabs and other products at the FDA’s urging because of potential contamination with Bacillus cereus bacteria and other organisms.

For Shanoop and Sandra Kothari, parents of the Houston toddler, it makes a difficult anniversary even tougher.

“You’ve got something hanging over you that’s not anything but a constant reminder of the loss,” said Jim Perdue, the Texas lawyer representing the Kotharis in a lawsuit filed in February.

Harrison Kothari, 2, died Dec. 1, 2010, after contracting a meningitis infection caused by Bacillus cereus. His parents blame tainted Triad wipes for the death.

H&P Industries officials and lawyers did not respond to msnbc.com requests for comment about the company’s future plans. Nor would they comment on industrial real estate listings that show that the firm’s 285,000-square-foot plant at 700 W. North Shore Drive in Hartland is for sale for $14.2 million. A representative for The Dickman Company Inc. on Wednesday said the site was an active listing.

The FDA has a mixed record with enforcing good practices at the Wisconsin medical supply plant and other manufacturers of medical wipes. Records obtained by msnbc.com showed officials failed to issue warning letters or demand other sanctions despite documented problems with sterilization and contamination dating back to 2009, and nearly a decade earlier. When officials finally did investigate, they demanded seizure of more than $6 million in H&P Industries products and, later, the plant closure.

H&P Industries was only the first medical supply firm to recall potentially tainted products this year. In September, Professional Disposables International Inc., or PDI, of Orangeburg, N.Y. voluntarily recalled all lots of five different kinds of non-sterile alcohol prep padsbecause of potential contamination with Bacillus cereus.

In April, Rockline Industries of Springdale, Ark., recalled nearly a million units of baby wipes, including brands sent to Walmart and Winn Dixie Stores because of potential contamination with Enterobacter gergoviae, a bacterium that can cause serious infections in babies and people with compromised immune systems. As first reported by the Milwaukee Journal Sentinel, Rockline Industries had similar trouble with contamination dating back to 2006, but the FDA took no enforcement action.

The FDA’s crackdown on H&P Industries and the Triad Group came only after msnbc.com reports sparked the interest of Sen. Michael Bennet, D-Colo., and Sen. Lamar Alexander, R-Tenn., who demanded explanations from the FDA after residents of their states said they were sickened by bacterial contamination from alcohol prep wipes, swabs and other products recalled by the Wisconsin firms. 

Under terms of the consent decree agreed to by H&P Industries and the FDA, the reconditioning plans are supposed to describe specific steps for correcting bacterial contamination and other violations.

The family-owned firms, run by brothers David R. Haertle and Eric C. Haertle and their sister, Donna L. Petroff, were shuttered in June after world-wide recalls of alcohol wipes and swabs and povidone iodine products found to be potentially contaminated with dangerous bacteria, including Bacillus cereus.

The consent decree lays out specific steps the company must follow in order to resume operations, including revamped quality assurance steps and new management to oversee it.  If the firms fail to comply, the company and its individual officers can face steep fines and other sanctions. But it doesn’t reveal how the company plans to meet those demands.

The firms face at least 10 lawsuits in several states filed by families who claim contaminated alcohol pads led to serious infections and, in at least three cases, deaths. The Kotharis were the first to seek legal action.

Other alleged deaths include a  69-year-old Alabama woman, Ruby Hutcheson, who died in August days before she was scheduled to give a deposition in her suit against H&P Industries. The family of a 66-year-old Illinois man, Garry Rockett, also claimed in a July lawsuit that he died in 2009 after being treated for cancer using contaminated Triad wipes.

The latest lawsuit was filed in November by a 57-year-old Washington, D.C., multiple sclerosis patient who said he developed a Bacillus cereus infection after using tainted wipes made by H&P Industries and the Triad Group and supplied by Bayer Healthcare Pharmaceuticals. William Preston West Jr. is seeking $10 million in compensatory and punitive damages; his wife, Carolyn B. Gleason, is seeking $1 million.

See msnbc.com full series: Tracking Tainted Wipes