August 2, 2012 — Zee antiseptic swabs, Dukal antiseptic wipes, and Dukal BZK swabs are being voluntarily recalled after inspectors from the U.S. Food and Drug Administration (FDA) found some lots were contaminated with the bacteria Burkholderia cepacia.
No injuries have been linked to the contaminated antiseptic wipes and the voluntary recall is seen a s a precautionary measure. Healthy adults are unlikely to be seriously injured by the bacteria.
However, it is possible that children, the elderly, or people with weakened immune systems (such as those with cancer or HIV) could potentially contract a serious infection.
The swabs and wipes being recalled are manufactured for Dukal by Jianerkang Medical Dressing Co., a Chinese-based medical products company located in Jintan City in Jiangsu Province, China. The contamination was discovered during routine port inspection for products imported into the United States. The products are made with benzalkonium chloride and are sold individually and in kits.
Company officials stated in the official recall announcement, “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.”
This antiseptic wipe recall follows several high-profile recalls last year. Two Wisconsin-based companies, H&P Industries Inc. and the Triad Group, initiated a massive recall of antiseptic swabs and wipes after an FDA inspection found serious microbial contamination. The facilities are still closed. The companies faced nearly 12 lawsuits from people who contracted infections after using the products — including the family of a 2-year-old boy from Houston. The boy contracted an infection from the Bacillus cereus bacteria, the same one that contaminated the H&P wipes. That lawsuit was settled in April 2012.
In 2011, there were two other product recalls for contaminated wipes. The first occurred in April 2011, when almost one million packages of baby wipes were recalled due to bacterial contamination. Another recall occurred in September when a New York company recalled non-sterile prep pads due to bacterial contamination.