USA – Mavidon Issues Voluntary Worldwide Recall of LemonPrep® Tubes and Single Use Cups

FDA

LemonPrep tubes and cups

Company Announcement

Mavidon is voluntarily recalling 21 lots of LemonPrep® 4 ounce tubes and single use cups to user level. These products have been found to be contaminated with Burkholderia cepacia. The specific lots are listed below:

Product Product # Lot#
LemonPrep 4 oz Tubes MD0019-T 29824, 29901, 30006, 30145, 30236, 30352,
30675, 30729, 31138
LemonPrep Single Use Cups MD0019-SUP 29927, 30009, 30031, 30115, 30059, 30237,
30300, 30340, 30424, 30642, 30735, 31139

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. Additional testing is ongoing to determine if there are other affected lots.

Leave a comment