The DUKAL Corporation just implemented a nationwide recall of select lots of benzalkonium chloride swabs and antiseptic wipes manufactured for DUKAL by Jianerkang Medical Dressing Co., the U.S. Food & Drug Administration (FDA) just announced. The benzalkonium chloride antiseptic wipes are sold separately, over-the counter (OTC), and in kits. The recall was implemented over concerns about potential microbial contamination with the bacteria Burkholderia cepacia (B. cepacia).
According to the U.S. Centers for Disease Control & Prevention (CDC), B. cepacia is a group or “complex” of bacteria found in soil and water and is often resistant to common antibiotics. People with certain health problems, such as weakened immune systems or chronic lung diseases, particularly cystic fibrosis, may be more susceptible to infections with B. cepacia. B cepacia is a known cause of infections in hospitalized patients and can lead to serious respiratory infections.
Consumers are advised to discontinue use of these recalled products immediately. To date, there have been no reported incidents involving these products.
DUKAL advises distributors and kit packers that include benzalkonium chloride swabs or antiseptic wipes as a component in their kits, to discontinue use of the recalled product and initiate a sub-recall to their customers; distributors and kit packers should return product in their inventories to DUKAL. The recalled DUKAL swabs and antiseptic wipes were distributed nationwide at the wholesale and retail levels. A complete list of involved products can be accessed at: http://www.fda.gov/Safety/Recalls/ucm313912.htm.
This recall is for BZK products still within product expiration dates. DUKAL’s customer support team can be reached, Monday to Friday, from 8:30 a.m. to 5:30 p.m., Eastern Time, toll-free at 1.800.243.0741, or by email to email@example.com.
As we’ve written, Bacillus cereus was one of the bacteria involved in the massive Triad Group and H&P Industries recalls linked to a number of illnesses and deaths. Both Triad Group and H&P Industries Inc. were accused of manufacturing and distributing alcohol products allegedly tainted with the dangerous bacteria Bacillus cereus and Elizabethkingia meningoseptica, both known to lead to rare and deadly infections.
We previously reported that U.S. Marshals seized $6 million worth of medical products from H&P Industries Inc., which does business as Triad Group, at the behest of the FDA. The raid was prompted by the failure of H&P Industries to comply with the FDA’s current good manufacturing practice (cGMP) regulations. Triad Group issued several massive recalls of tainted alcohol prep pads, alcohol swabs, alcohol swabsticks, and other products sold under various brand names and because of potential Bacillus cereus contamination. H&P Industries issued a Povidone Iodine Prep Pad recall because of concerns they could be contaminated with Elizabethkingia meningoseptica, which is associated with flesh-eating bacteria disease, meningitis in newborn infants, and pneumonia in ventilator patients.
At least 11 lawsuits have been filed, nationwide, alleging that the tainted wipes led to serious infections, illnesses, or deaths. Meanwhile, Pacific Disposables Inc. of Orangeburg, New Jersey issued a recall last fall of 300 million individual prep-pads last fall over potential contamination with the same type of bacteria.