On December 23, 2019, Mavion warned hospitals, clinics, and customers to immediately stop using all of their products due to contamination with the bacteria B. cepacia.
Mavidon has received one report of a baby who developed an infection with B. cepacia after it was treated with LemonPrep.
The FDA reported that tests on samples of 114-gm tubes of Lemon Prep were contaminated with B. cepacia. In response, Mavidon recalled all products manufactured at the facility.
B. cepacia is a multi-drug resistant bacteria that can cause life-threatening infections in healthy adults as well as people with vulnerable immune systems, such as infants or cancer patients.
The recall involves products such as Lemon Prep®, Pedia Prep®, Wave Prep®, and Cardio Prep® Single-Use Cups, which are used in hospitals and clinics as skin-prepping lotions.
The recall also involves products that are used to remove oils and skin residue. Collodions, Collodion Remover, Medical Adhesive Remover, Acetone are used to attach and remove EEG electrodes.
The recall is an expansion of a previous recall in September 2019 for LemonPrep® after an adverse event was reported in an infant.