Chinese-made antiseptic wipes and swabs distributed in the U.S. by a New York medical supply company have been recalled because of potential microbial contamination.
DUKAL Corp. of Ronkonkoma, N.Y., issued a nationwide voluntary recall of 4,300 cases of benzalkonium chloride swabs and antiseptic wipes, saying they may contain Burkholderia cepacia, bacteria that can cause infection and illness in people with underlying health problems. The recall was issued on July 25, but posted by the U.S. Food and Drug Administration on Wednesday.
“All customers are advised to discontinue use of products identified in this recall immediately as their use could lead to infections, some of which pose certain health risks in immune-suppressed patients,” the company said in a statement.
Two of some 50 lots of products, including Zee antiseptic swabs and Dukal BZK swabs, were found to contain the bacteria, John Grasso, vice president of operations for DUKAL, told NBCNews.com.
“We’ve actually recalled the product back to 2009,” Grasso said.
The swabs were manufactured by Jianerkang Medical Dressing Co. The company’s website indicates it’s located in Jintan City in Jiangsu Province, China.
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Grasso said FDA officials detected the contamination during a routine port inspection of imported products. The problem was traced to a faulty machine at the Chinese plant, he added. It has since been resolved.
DUKAL makes a wide range of medical products including antiseptics and cleansers, bandages, tapes and gauze dressings. Many of those products are included in first-aid kits and medical kits sent to people with medical problems. They are sold both over-the-counter and as part of kits.
No illnesses have been associated with the potentially tainted products, Grasso said.
“For average healthy people, the presence of Burkholderia cepacia is not likely to cause serious health risks,” the company said.
FDA officials could not immediately comment on results of inspections or other enforcement actions at the Chinese plant.
Echoes of past tainted wipe recalls
The recall of antiseptic wipes comes more than a year after a massive recall of swabs, wipes and other products made and distributed by sister Wisconsin firms highlighted serious health risks and regulatory failures regarding microbial contamination in medical supplies.
As of June, FDA officials said H&P Industries Inc. and the Triad Group of Hartland, Wis., remained closed under the terms of a federal consent decree that prohibits the firms from making or distributing products.
The firms have been cited in nearly a dozen lawsuits nationwide that alleged that contaminated wipes or other products led to serious illnesses and death.
The family of a 2-year-old Houston boy, Harrison Kothari, alleged that he died after contracting an infection caused by Bacillus cereus, the bacterium detected in the H&P wipes. The boy’s parents, Sandra and Shanoop Kothari, settled their lawsuit with H&P Industries in April, according to court records and interviews.
Other wipe-makers have recalled products because of potential contamination as well. Last September, Professional Disposables Inc. of Orangeburg, N.Y., recalled all lots of five different kinds of non-sterile alcohol prep pads because of possible contamination with Bacillus cereus.
And in April 2011, Rockline Industries of Springdale, Ark., recalled nearly a million units of baby wipes, including brands sent to Winn-Dixie stories and Walmart, because of potential contamination with Enterobacter gergoviae.
In February 2011, as scrutiny of the Triad alcohol prep pad recall was heating up, the DUKAL Corp. issued a press release from its Shanghai office.
"Dukal's alcohol wipes are manufactured in accordance with all applicable FDA guidelines and strictly controlled and monitored by Dukal's quality assurance department," the release said.
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