August 2, 2012 — The U.S. Food and Drug Administration (FDA) has announced a nationwide voluntary recall of antiseptic wipes, Zee antiseptic swabs, and Dukal BZK swabs. The wipes and swabs are made with benzalkonium chloride and manufactured for Dukal by Jianerkang Medical Dressing Co, a Chinese company. The products are sold over-the-counter and in kits.
The FDA is issuing an immediate recall because they are concerned about potential contamination with the bacteria Burkholderia cepacia. Although the bacteria is unlikely to cause serious illness to a healthy adult, it could be dangerous for a person with a weakened immune system (such as those undergoing cancer or HIV treatment).
There have been no reported incidents or injuries related to these products, and the recall is precautionary.
In a statement, the company said, “All customers are advised to discontinue use of products identified in this recall immediately as their use could lead to infections, some of which could pose certain health risks in immune-suppressed patients.”
The FDA discovered the contamination during routine inspection of medical products being imported from China. The contamination was traced to a facility owned by Jianerkang Medical Dressing Co., located in Jintan City in Jiangsu Province, China.
This is not the first recall of antiseptic wipes. Last year, H&P Industries, Inc. and the Triad Group, two companies located in Hartland, Wisconsin, initiated a massive recall of swabs and wipes due to serious microbial contamination. The companies are now prohibited form distributing products. They face nearly a dozen lawsuits from people who claim that the contaminated wipes caused severe infections. One of the lawsuits was filed on behalf of a 2-year-old boy from Houston who died of an infection from Bacillus cereus, the same bacteria found on the H&P wipes. H&P settled their lawsuit in April.
There were also two contaminated wipe recalls in 2011. One was initiated in September by Professional Disposables Inc., a company located in New York. That recall involved five types of non-sterile alcohol prep pads. Another recall occurred in April, when Rockline Industries recalled nearly one million units of baby wipes.
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