6th January 2020 Author: Paul Carton
Burkholeria cepacia Contamination Results in Total Recall of Mavidon Products
Mavidon, a medical device manufacturer, has informed all of its customers, hospitals and clinics to stop using and quarantine all of its products immediately because of possible contamination with Burkholderia cepacia.
The recall comes 4 days after the FDA notified the company of the contaminant, which was found during testing of samples of Mavidon's LemonPrep®, which were taken by the FDA in an inspection in October. The LemonPrep product along with other products recalled, have uses which include abrasive skin prepping lotions; products intended to lower skin impedance and enhance the signal quality at the electrode site.
In September Mavidon recalled batches of LemonPrep due to possible contamination with B. cepacia and received one report of adverse event in a neonate related to this product.
Date Published: 6th January 2020
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