Medical Device Product Recall | Mavidon

THE RECALL

Today, a voluntary product recall was issued for Hospitals and  Clinics to stop using Mavidon which is also known by brand names of LemonPrep, PediaPrep, Wave Prep, Cario Prep.  These are 4 -ounce tubes and single use cups, cardio Prep and Collodions, Collodion removers, medhical adhesive remover, acetone and all products manufactured by Mavidon need to STOP using the products immediately.

These products were distributed to hospitals, clinics and distributors across the USA and around the world.

REASON BEHIND RECALL

They have issued this recall due to contamination with Burkholderia cepacia, which is the name for a group or “complex” of bacteria that can be found in soil and water. B. cepacia bacteria are often resistant to common antibiotics.

Contaminated products with this could potentially result in serious infections to life-threatening situations for those with weakened immune systems, such as babies, elderly, pregnant women, cancer patienties and in some cases, healthy people.

The CDC states that B. cepacia can also be spread to susceptible persons by person-to-person contact, contact with contaminated surfaces and exposure in the environment.

The effects of B. cepacia on people vary widely, ranging from no symptoms at all to serious respiratory infections, especially in patients with cystic fibrosis.

REPORTED INCIDENTS

At the time of a FDA inspecition of their facility after taking samples of the 114gm tubes of the Lemon prep on October 15, 2019, was found to be contaminated by this product.  The facility received the results and notified the lab on December 15, 2019.

RELATED OTHER CASES WITH SAME CONTAMINATION RECORDED

In 2005, CDC was notified by several states of clusters of pneumonia and other infections caused by B. cepacia and associated with contaminated mouthwash.

CUSTOMER NOTIFICATIONS (Hospitals & Clinics)

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 cs@mavidon.com.

CONSUMER QUESTIONS

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.

SOURCES

FDA.gov is a government site that lists product recalls.  For more information regarding this recall, go to this article at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mavidon-issues-voluntary-worldwide-recall-all-manufactured-products-due-burkholderia-cepacia

CDC https://www.cdc.gov/hai/organisms/bcepacia.html

NW Fire Blog – Updated 2030 Hours PST – Monday, 12/23/2019