The United States Food and Drug Administration (FDA) has posted a company announcement concerning medical devices manufactured by Mavidon due to Burkholderia cepacia contamination. The details of the affected medical devices are identified as follows:
The manufacturer is voluntarily recalling all lots of the affected products manufactured at its facility due to contamination with Burkholderia cepacia. It was notified on 19 December 2019 that samples of 114gm tubes of Lemon Prep, collected during a FDA inspection that occurred at its facility on 15 October 2019, were tested and found to be contaminated with Burkholderia cepacia.
Burkholderia cepacia is a multi-drug resistant pathogenic microorganism. Contaminated products with Burkholderia cepacia can potentially result in serious infections, may be life-threatening for patients with compromised immune systems, such as neonates, elderly, pregnant women, cancer patients, but also in previously healthy individuals. According to the manufacturer, it has received one report of adverse event in a neonate related to the affected products.
Users are advised to immediately stop using the affected products and quarantine them.
Product recall is on-going.
If you are in possession of the products, please contact your supplier for necessary actions.
For details, please refer to the following link:
https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mavidon-issues-voluntary-worldwide-recall-all-manufactured-products-due-burkholderia-cepacia
Posted on 27 December 2019