Mavidon Issues Voluntary Worldwide Recall of Manufactured Products Including Lemonprep® Tubes And Single Use Cups Pediaprep® Tubes And Single Use Cups Wave Prep® Tubes And Single Use Cups Cardio Prep Single Use Cups Due To Burkholderia Cepacia Contamination

Summary

Company Announcement

Mavidon is notifying customers, we are amending our recall and have removed Collodions, Collodion Remover, Medical Adhesive Remover and Acetone from the recall.

Hospital and clinics to STOP using LemonPrep, Pedia Prep, Wave Prep, Cardio Prep manufactured by Mavidon in the Riviera Beach, FL Facility IMMEDIATELY due to potential contamination with Burkholderia cepacia.

Mavidon is voluntarily recalling all lots of products manufactured at our facility including LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep single use cups due to potential contamination with Burkholderia cepacia. We were notified on December 19, 2019 that samples of 114gm tubes of Lemon Prep, collected during a Food and Drug Administration inspection that occurred at our facility on October 15, 2019 were tested and found to be contaminated with Burkholderia cepacia. Out of an abundance of caution, we are recalling all products manufactured at our facility.

Actions to be taken:

1. Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it.
2. Fill out the Medical Device Recall form below and email it to CS@mavidon.com
3. We will follow up and give instructions on how to return the product for credit

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.

Mavidon is notifying of all of its customers by email and phone of this recall. Contact Mavidon at 800-

• /MedWatch/ getforms.htm) or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre- addressed form, or submit by fax to 1-800-FDA-0178

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

Link to the Original Recall