Selected lots of benzalkonium chloride swabs and antiseptic wipes manufactured for DUKAL by Jianerkang Medical Dressing Co. and sold over-the-counter and in kits are being recalled because of potential microbial contamination with Burkholderia cepacia. All customers are advised to discontinue use of the recalled products immediately as using them could lead to infections, some of which pose certain health risks for immune-suppressed patients.
Burkholderia cepacia is an important human pathogen that often causes pneumonia in people with underlying lung diseases such as cystic fibrosis or chronic granulomatous disease. For average healthy people, the presence of Burkholderia cepacia on the recalled products is not likely to cause serious health risks. The recall was initiated in an effort to prevent the potential risk. To date, there have been no reported incidents involving the products.
Benzalkonium chloride swabs and antiseptic wipes are used externally to prevent infection and are often used to clean wounds. Customers who have the affected products in their possession are urged to discontinue use immediately.
For more information regarding this recall and whether to dispose or return the product, call customer support Monday through Friday from 8:30 a.m. until 5:30 p.m. Eastern time at 800-243-0741, or email email@example.com.
Any side effects following use of these products or quality issues should be reported to the Food and Drug Administration (FDA) MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.Report.htm.