Triad Product Recalls
Triad Lubricating Jelly Recall
In December 2010, Triad Group initiated a recall of 18 lots of sterile lubricating jelly due to questionable sterility of the product. The jelly was sold under the brand names:
- Henry Schein
- McKesson MediPak Performance
- Select Medical Products
- Triad Plus
It is routinely used to lubricate the insertion of a medical device or gloved fingers into body openings. Ensuring sterility of the jelly is vital to prevent bacteria from entering the body and uphold the health of the patient.
Recalled jelly products were distributed by Triad between January 2007 and December 2010. They include packages sold in 5-gram, 2- and 4-ounce tubes, and 3- and 5-gram packets. The jelly may have been sold alone or packaged into kits, packs and trays.
Below is a chart of all the recalled jellies:
|BRAND NAMES||FIRM NAMES||CATALOG #
|Allegiance||Cardinal Health||LJT2||Net Wt. 2 oz.|
|LJF3||Net Wt. 3g|
|LJT4||Net Wt. 4 oz.|
|LJT5||Net Wt. 5g|
|Select Medical Products||PSS World Medical, Inc.||137||3g/packet|
|Novaplus||Novation, Inc.||V10-8344||Net Wt. 3g|
|V10-8919||Net Wt. 4 oz.|
|V10-8917||Net Wt. 2 oz.|
|Triad||Triad Group, Inc.||Oct-17||Net Wt. 2 oz.|
|Triad Plus||Oct-46||Net Wt. 5g|
|Nov-44||Net Wt. 3g|
|Nov-72||Net Wt. 5g|
|Oct-19||Net Wt. 4 oz.|
|Oct-00||Net Wt. 4 oz.|
|IMCO||Independent Medical Co-op, Inc.||8919-IMC||Net Wt. 4 oz.|
|McKesson Medi-Pak Performance||McKesson Corporation||66-8919||Net Wt. 4 oz.|
|Henry Schein||Henry Schein, Inc.||104-9637||Net Wt. 4 fl. oz.|
Triad Alcohol Swab & Prep Pad Recall
January 2011 saw another recall for Triad on the heels of the devastating death of a young boy. Harrison Kothari, a 2-year-old from Houston, was fatally infected with the same bacteria that led to Triad’s recall of tens of millions of alcohol pads and swabs.
The company removed their non-sterile alcohol prep pads and swabs from the market due to concerns of a potential contamination with Bacillus cereus. Bacillus cereus is a bacterium that can be harmful to humans. According to the U.S. Centers for Disease Control and Prevention, this bacterium is responsible for approximately two percent of all food-borne illnesses. Within 24 hours of exposure, affected persons will fall ill, often with symptoms such as diarrhea.
With Triad wipes introducing bacteria where it is not normally expected, other instances of complications have been reported. Injures range from superficial skin infections to more serious problems and one other claim of a death. A spokesperson for the Food and Drug Administration said over 100 reports of problems with alcohol prep pads have been logged with the FDA in the weeks following the Jan. 5 recall.
The FDA’s Part
The FDA’s role in the contaminated Triad products is cause for concern as well. MSNBC.com aired government documents indicating that FDA inspectors knew about problems with contamination and sterilization at a Triad pant in Hartland, Wis. as early as July 2009. An FDA inspection report states: “Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.”
Other inspections between April 19 and May 18, 2010 again reported that Triad could not validate the processes used to ensure quality or sterility of alcohol prep pads and wipes, as well as other products used for intimate care. Inspectors found Triad’s processes to sterilize the lubricating jelly to be inadequate. Triad’s manufacturing equipment was worn and broken, and their quality standards for products were inconsistent. The FDA has not denied the existence and authenticity of these reports, nor has the FDA assumed any responsibility for Triad’s continued production of defective products or the injuries caused by those products.
It appears that Triad blatantly disregarded safety regulations and has supplied unsafe products to consumers. If you or a loved one has suffered injury from one of the recalled Triad product, you deserve compensation. Please contact the attorneys at Childers, Schlueter & Smith, LLC, who have extensive knowledge of the Food and Drug Administration regulations, as well as product liability law. Contact Childers, Schlueter & Smith, LLC for more information or to get answers to any related questions you may have.