Last year, a Texas toddler died of bacterial meningitis caused by Bacillus cereus, the rare bacterium later linked to the recall of millions of alcohol prep wipes.
A 66-year-old man, who received outpatient treatment for skin cancer and diabetes, died after Bacillus cereus infected his blood. So far, there are eight reports of fatalities, 11 infections and nearly 250 other problems associated with medical products manufactured and distributed by the Triad Group and H&P Industries Inc. of Hartland, Wisconsin, according to an MSNBC report and the Food and Drug Administration.
The Milwaukee Journal Sentinel reported that FDA officials had known about problems with cleanliness and quality control at H&P’s plants for at least a decade but did not take enforcement action. In 2009, the FDA noted 21 violations of good manufacturing practices, which are a set of guidelines used to assure public safety, including dirty equipment, failure to properly sterilize, and failure to report health-related complaints.
There were 2 additional FDA inspections before people began to get sick in a Colorado hospital from contaminated Triad Group products. Inspectors then scoured the plant for weeks and found 46 violations of good manufacturing practices, noting “Sterile alcohol prep wipes were found to be contaminated with Bacillus cereus organisms and were released for shipment after confirmation of the results”.
The Triad Group has denied that its alcohol wipes are linked to any deaths or injuries. The company, which is now closed after massive recalls of alcohol wipes, is in turn suing a vendor who canceled orders and refused payment after reports of bacterial contamination were made public earlier this year. The Triad Group’s lawsuit alleges that the vendor’s particular products weren’t affected and stated in their complaint “There is no evidence of any such contamination affecting any such Germ-X products”.
Update: The parents of the child that died as a result of the contaminated wipes have settled their lawsuit againt The Triad Group, citing a reluctance to go to trial. The settlement details were not available as other lawsuits against the negligent company. The company still denies wrongdoing.