WASHINGTON, D.C. — The medical device manufacturer Mavidon recalled its products worldwide after learning that they could be contaminated with Burkholderia cepacia.“Burkholderia cepaciais a multi-drug resistant pathogenic microorganism,” according to a press release published by the U.S. Food and Drug Administration (FDA) recently. Although the recall is voluntary, according to the FDA, Mavidon must pull all of its products sold domestically and internationally as well to avoid spreading the potentially deadly infection. Mavidon is aware that one of its products contributed to a child hospitalized in a neonatal unit to contract the infection. There was no information available about the outcome of that case.
Mavidon must recall all of its products from worldwide distributors because of the danger of spreading Burkholderia cepacia.The company distributes products under the brand names of LemonPrep, PediaPrep, Wave Prep, and Cardio Prep. The company said that its LemonPrep, PediaPrep, and Wave Prep were sold in four-ounce tubes as well as cups designed for single use. Additional products recalled include Cardio Prep and Collodions, along with Collodion removers.
Mavidon warned all of its customers that they must stop using its products immediately due to the threat of infection. Mavidon said that the FDA collected samples of its LemonPrep in the 114gm tubes for testing. The results of the inspection revealed the presence of Burkholderia cepacia. As a result of the examination, Mavidon decided the most prudent course of action was to recall its products.
Burkholderia cepacia is a complex of various bacteria that grow resistant to typical antibiotic treatments. People who live with compromised immune systems, are older, or young children, especially neonates, people who have cancer, and pregnant women are susceptible to developing a life-threatening infection. Burkholderia cepacia has been known to cause fatal infections in healthy adults as well.
The FDA said that Mavidon learned of one case of Burkholderia cepacia infection from its products. That infection occurred in a neonate child.
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