Mavidon is voluntarily recalling 21 lots of its skin prepping lotion, LemonPrep, due to bacterial contamination.
The Riviera Beach, Fla.-based medical devicemaker said Burkholderia cepacia, a multi-drug resistant pathogen, was found in the lotion. The product is used to remove oils and skin residue on patients.
The FDA warned the contaminated products can potentially cause serious infections that could be life-threatening for both healthy patients and those with compromised immune systems.
Mavidon has received one report of an adverse event with the recalled product involving an infant.
The lots were distributed to hospitals in the U.S., Canada, Australia, Spain, England and The Netherlands from September 2017 to January 2019.
The FDA warned hospitals to stop use and quarantine the product immediately.
Additional testing is ongoing to determine if more lots are affected.
Read the full news release here.
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