As a supplier of Mavidon® products in the UK and Ireland we feel it is important to make our customers aware of the recent recall notice issued by the manufacturer. Important, if you have purchased these products from Biosense Medical Limited and feel you might be affected please get in touch with us directly and not by contacting Mavidon directly.
Letter from the President of Mavidon®
RE: Mavidon Recall December 24, 2019 (https://www.mavidon.com/)
We are working diligently at our facility and in coordination with the FDA in regards to Mavidon’s voluntary recall because of the potential Burkholderia cepacia contamination.
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. To date, Mavidon has received one report of adverse event in a neonate related to this product in recall.
Burkholderia cepacia (BC) has been found most recently in tubes of LemonPrep. The root cause was found in our deionized filtered water. We have since replaced this system and added a second (post-filter) ultraviolet light water filtration system. We are in the process of extensively sanitizing our filling and packaging line and will be performing extensive testing before we offer our skin prep products on the market. These products include LemonPrep, Pedia Prep, Wave Prep and Cardio-Prep. In the meantime please quarantine these products and fill out the form on the recall letter for replacement when we are able to ship these products. In the meantime please use alternative sources for your skin preparation needs.
For Collodions, Collodion Remover, Medical Adhesive Remover and Acetone, these products do not contain any water and they are manufactured on separate filling and packaging lines. We will work with the CDRH to ensure these products are safe. In the meantime, please quarantine what you have in stock until further notice.
We understand that these latter products are necessary for many important procedures that may or may not be a life safety issue. Since 1986 we have supplied collodion and are the only source available, that is registered with the FDA.
We are working diligently to receive clearance for these products.
Thank your for your patience,