- Company Announcement Date:
- December 23, 2019
- FDA Publish Date:
- December 23, 2019
- Product Type:
- Medical Devices
- Reason for Announcement:
Recall Reason Description
- Company Name:
- Brand Name:
LemonPrep®, PediaPrep®, Wave Prep, Cardio Prep
- Product Description:
LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, Collodion removers
Mavidon is notifying customers, Hospital and clinics to STOP using 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 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 and Collodions, Collodion removers due to 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.
Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it.
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.
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. We are including in this worldwide recall all of our products as it is possible that contamination with B. cepacia may have taken place and gone undetected before distribution. We pledge ourselves to the highest standards of quality and out of abundance of caution we have decided to recall all products made at our facility.
Mavidon is notifying of all of its customers by email and regular mail. Contact Mavidon at 800-654-0385 (Monday – Friday, 8:30 AM to 5:00 PM EDT) or by email to [email protected].
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 [email protected]. 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.
- Complete and submit the report Online
- Regular Mail or Fax: Download form 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 Original Recall