FDA Announces Amendment of Mavidon’s Voluntary Worldwide Recall On Various Manufactured Medical Devices over Burkholderia cepacia
On December 23, 2019, Mavidon, a medical device and collodion producing company, recalled all products produced by its facility in Riviera Beach, FL due to its contamination with Burkholderia cepacia. The prior recall included all LemonPrep®, PediaPrep® and Wave Prep 4-ounce tubes and single use cups, Cardio Prep and Collodions, and Collodion remover products. The company has just amended its prior recall to exclude Collodions, Collodion Remover, Medical Adhesive Remover and Acetone from the recall list.
The company was notified about the contamination in their facility on December 19, 2019. During an inspection on October 15. 2019, The Food and Drug Administration took 114 gm tubes of Lemon Prep, which later returned positive for Burkholderia cepacia. Out of caution for their clients, Mavidon issued a voluntary recall on all associated manufactured products from its Riviera Beach, FL facility. There has been one reported case of a child adversely affected by the contamination.
According to the CDC, Burkholderia cepacia is a group or “complex” of bacteria which commonly colonize in hospital medicines and equipment. Burkholderia cepacia does not usually pose a threat to healthy individuals. However, those with weakened immune systems such as the young, elderly, pregnant, or very ill are at a higher risk for infection and complications. The CDC notes that people with cystic fibrosis are particularly at risk for infection.
Mavidon has published the following statements and request that hospitals and clinics in possession of any of the recalled items comply with the following precautions:
- Stop using the product and quarantine it.
- Fill out the Medical Device Recall form below and email it to CS@mavidon.com
- We will follow up and give instructions on how to return the product for credit
Any updates on the standing of this recall can be found on the U.S. Food and Drug Administration’s website.