Infection Risk Triggers New Recall Of Wipes
MSNBC.COM - A Wisconsin medical supply firm blamed for serious infections and death from tainted alcohol prep wipes has issued a new nationwide recall for another product potentially contaminated with different dangerous bacteria.
H&P Industries Inc., the parent company of the Triad Group of Hartland, Wis., has recalled all lots of povidine iodine prep pads used to prevent infections in cuts, scrapes and burns and in preparation for surgery.
The recall notice says the pads may be contaminated with Elizabethkingia meningoseptica, an organism that has caused rare but serious infections in humans, including meningitis in newborn infants, pneumonia in patients on ventilators and necrotizing fasciitis, more commonly known as flesh-eating bacteria disease.
A press release issued by the company but not posted on the firm's website says that the new recall has been initiated because of results of investigation and sampling tests conducted by the federal Food and Drug Administration and the firm's own internal investigation.
The newly recalled products include povidine iodine prep pads made by H&P Industries Inc. and packaged under the names Cardinal Health, Medical Specialties, VHA, Triad, Triad Plus, North Safety and Total Resources. It's not clear how much product the new recall covers. There are no reported illnesses from the contaminated pads.
The FDA has issued no notice of the recall, which was announced late Wednesday. FDA officials could not immediately be reached for comment. Triad Group chief operation officer Eric Haertle, who issued the recall, did not respond to an e-mail from msnbc.com.
Company officials issued the notice under the H&P Industries name, not the Triad Group name, and have changed all documents on the Triad Group site to H&P letterhead.
The new recall comes more than two months after H&P Industries issued a global recall of hundreds of millions of contaminated alcohol prep pads and wipes because of potential contamination with a rare bacteria, Bacillus cereus.
A Colorado hospital cultured the potentially life-threatening bacteria from the Triad Group wipes after children came down with bloodstream infections caused by the organism. Triad Group is facing at least two lawsuits from people who became infected with Bacillus cereus blamed on the wipes, including a 2-year-old Houston boy who died in December from bacterial meningitis.
Government inspection records show that FDA officials knew as early as 2009 that company had serious problems with contamination and sterilization at its Hartland, Wis., plant. But an FDA official said the agency did not detect an imminent public health hazard until the Colorado infections were reported.
FDA officials have refused to comment on the outcome of a new investigation of H&P Industries and the Triad Group. A spokeswoman, Shelly Burgess, says the investigation is continuing.
Last month, Triad officials sent a letter to customers, vendors and employees saying they were shutting down the line that produced the alcohol wipes and lubricating jelly, which has also been found to be contaminated. The move was initiated in part because of news reports by msnbc.com, as well as the FDA investigation and pending lawsuits.
Elizabethkingia meningoseptica, formerly known as Chryseobacterium meningosepticum, is a bacterium often found in frogs and fish and elsewhere in nature, but rarely linked to human infections.
It was discovered in 1959 by American bacteriologist Elizabeth O. King, who isolated an organism linked to meningitis in infants.
In recent years, the bacteria have been tied to orthopedic infections caused by tissue from deceased donors, according to a 2010 paper published in the Journal of Bone and Joint Surgery.
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