The FDA have issued the following notification, via its Medwatch service:
“FOR IMMEDIATE RELEASE - July 25, 2012 - Today, DUKAL Corporation announced a U.S. voluntary nationwide recall of selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for DUKAL by Jianerkang Medical Dressing Co.
Benzalkonium chloride antiseptic wipes are sold separately over-the counter and in kits.
This recall is being initiated due to concerns about potential microbial contamination with Burkholderia cepacia. 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. For average healthy people, the presence of Burkholderia cepacia on the swab is not likely to cause serious health risks.
To date, there have been no reported incidents involving these products. In an abundance of caution, we are voluntarily recalling these products to prevent any such potential risk. All customers should dispose of the product. All distributors and kit packers, who include benzalkonium chloride swabs or antiseptic wipes as a component in their kits, should discontinue use of the product and initiate a sub-recall to their customers. All distributors and kit packers should return product in their inventories to DUKAL. These products were distributed nationwide to the wholesale and retail levels.
DUKAL is deeply committed to providing high quality, reliable products and issues this recall as a precaution to ensure consumer safety. DUKAL continues to work closely with FDA to ensure our products meet or exceed FDA requirements.”
For further details, see FDA