Company Announcement Date: September 26, 2019

FDA Publish Date: September 26, 2019

Product Type: Medical Devices

Reason for Announcement: Burkholderia cepacia

Company Name: Mavidon

Brand Name: LemonPrep

Product Description: Skin prepping lotion for enhancement of signal quality at electrode site

Mavidon is voluntarily recalling 21 lots of LemonPrep® 4 ounce tubes and single use cups to user level. These products have been found to be contaminated with Burkholderia cepacia. The specific lots are listed below:

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. Additional testing is ongoing to determine if there are other affected lots.

The product is used as abrasive skin prepping lotion and designed to lower skin impedance and enhance the signal quality at the electrode site. This cleaning agent removes oils and skin residue on patients with normal to oily skin. The lot numbers can be identified on the LemonPrep® 4 ounce tubes can be found on the crimp and the outer box label. The single use cup lot numbers can be found on the cups and the other box label. These were distributed Worldwide to hospitals in USA, Canada, Australia, Spain, England, The Netherlands, from September 2017 to January 2019.

Mavidon is notifying its customers by email and is arranging for the replacement of all recalled products. Hospital and clinics that have product that is being recalled should immediately stop using the product and quarantine it. Contact Mavidon at 800-654-0385 (Monday – Friday, 8:30 AM to 5:00 PM EDT) or by email to cs@mavidon.com.

Consumers with questions regarding this recall can contact Mavidon at 800-654-0385 (Monday – Friday, 8:30 AM to 5:00 PM EDT) or by email to cs@mavidon.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to the use of this product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.