(Editor's Note: After U.S. marshals shut down Triad's Hartland, Wis., manufacturing facility in April 2011, Triad and its sister company, H&P Industries, filed for chapter 11 bankruptcy in August 2012. As of May 2013, court documents show(www.triad-group.net) the two companies still were disputing nearly $28 million in product liability claims.)
The Triad Group is recalling all lots of its alcohol prep pads, swabs and swabsticks, which are used to disinfect skin prior to injections or IV insertion. These products could expose patients to the pathogen Bacillus cereus.
The FDA said in a Jan. 6 safety alert(www.fda.gov) that use of contaminated products could lead to life-threatening infections, especially in at-risk populations, including immunosuppressed and surgical patients.
The Triad Group said in a Jan. 5 news release(www.fda.gov) that it had received one report of a skin infection that was not-life threatening. The Hartland, Wis.-based manufacturer responded by recalling all lots of its alcohol prep pads, swabs and swabsticks.
"We are, out of an abundance of caution, recalling these lots to ensure that we are not the source of these contamination issues," the company said.
The recalled products are manufactured by Triad but have been sold as private-label OTC products and distributed nationwide to hospital and retail pharmacies. The products, which also were manufactured for and distributed to several wholesale customers, may use the following names in their packaging:
- Cardinal Health,
- PSS Select,
- Moore Medical,
- CVS and
In all, more than three dozen brand-name products are affected, according to a recall fact sheet posted on Triad's website.
Consumers are advised to not use the recalled products, which should be returned to the place they were purchased for a full refund, Triad said. Additional questions may be directed to Triad Group Customer Service at (800) 288-1288.
Physicians and patients should report adverse events or side effects related to the use of these products to the FDA's MedWatch program(www.fda.gov).