Mavidon is recalling all lots of Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep Single use cups, Collodions, Collodion Remover, Medical Adhesive Remover, Acetone and all products manufactured by Mavidon immediately due to contamination with multi-drug-resistant Burkholderia cepacia, a bacteria that may cause serious infection. The company has received one report of an adverse event in a newborn related to a product in this recall.
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.
Lemon Prep, Pedia Prep, Wave Prep, Cardio Prep Single Use Cups products have uses which include as abrasive skin prepping lotions, products intended to lower skin impedance and enhance the signal quality at the electrode site, cleaning agents to remove oils and skin residue on patients with normal to oily skin . Collodions, Collodion Remover, Medical Adhesive Remover, Acetone are used to attach and remove EEG electrodes. These were distributed to hospitals, distributors, and clinics in the USA and worldwide.
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