Announcement Issued by Mavidon:
Hospital and clinics are to STOP using LemonPrep®, PediaPrep®, Wave Prep, & Cardio Prep that were manufactured by Mavidon in their Riviera Beach, FL Facility IMMEDIATELY due to potential contamination with Burkholderia cepacia.
Mavidon is voluntarily recalling all lots of products manufactured at their 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.
Actions to be taken:
- Hospitals, distributors, and clinics that have any Mavidon products should immediately stop using the product and quarantine it.
- Fill out the Medical Device Recall form that can be found on the FDA.gov website or call 1-800-332-1088 to request a reporting form and email it to CS@mavidon.com
Symptoms of B. cepacia infection
Symptoms associated with infections caused by B. cepacia are very similar to the symptoms of other diseases of the lungs such as pneumonia and cystic fibrosis. These symptoms include:
- Shortness of breath
- Difficulty breathing
- Phlegm build-up/congestion
If the deterioration of the lungs progresses far enough, the lung function may decrease to the point that they may not be able to adequately supply the body with oxygen which may result in death.
Consumers: Contact Mavidon 800-654-0385 email@example.com