Mavidon, a medical device manufacturer specializing in products for the application of electrode leads and therapy products, has recalled several of its products for potential bacterial contamination. According to a news release from the US Food and Drug Administration, the company is notifying customers, hospitals, and clinics to stop using Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep Single-use cups, Collodions, Collodion Remover, Medical Adhesive Remover, Acetone, and all products manufactured by Mavidon right away due to contamination with Burkholderia cepacia (B.cepacia).
Details of the Recall
Mavidon has received one report of an infant who developed an infection with B. cepacia after being treated with LemonPrep. The company notified the FDA on Dec. 19 that samples of the 114-gram tubes of LemonPrep collected during an FDA inspection, were tested and found to be contaminated with the bacteria. The company said it is recalling all products manufactured at its facility out of an abundance of caution. Hospitals, distributors, and clinics with any Mavidon products are urged to stop using them immediately and isolate them.
The products that have been recalled are widely used to lower skin impedance and enhance the signal quality at the electrode site, as well as cleaning agents to remove oils and skin residue on patients with normal to oily skin. The products were distributed to hospitals and clinics in the United States and worldwide.
What is B. cepacia?
Burkholderia cepacia is a multi-drug resistance pathogenic microorganism. Products that are contaminated with this pathogen could result in serious infections that may be life-threatening for patients with compromised immune systems, such as babies, the elderly, pregnant women, cancer and HIV-AIDS patients, and so on. B. cepacia bacteria are resistant to many antibiotics, which makes them difficult to treat, primarily once they infect the lungs.
Suppose you or a loved one has been affected by these or other defective medical products. In that case, you may be able to file a product liability lawsuit against the manufacturer seeking compensation for damages, including medical expenses, lost income, hospitalization, cost of other treatments, pain and suffering, and emotional distress. An experienced product defect lawyer will be able to help you better understand your legal rights and options.
Source: https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mavidon-issues-voluntary-worldwide-recall-all-manufactured-products-due-burkholderia-cepacia
