CDC continues to work with FDA and state and local health departments in affected states to investigate an outbreak of Burkholderia cepacia complex (Bcc) infections associated with Medline Remedy Essentials No-Rinse Foam. Medline has issued a voluntary recall of all lots in three master batches of this product, which includes all lots beginning with the master batch numbers M05703, M06691, and M07247 (https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=162968). Investigation is ongoing to determine the underlying cause of contamination.
Samples of the product collected from Pennsylvania and California hospitals have tested positive for Bcc. Molecular testing comparing clinical and product isolates in PA to isolates from CA indicate that the isolates are closely related.
Facilities should follow the recall instructions for the recalled lots and consider avoiding the use of other lots of the product while further investigation is being conducted. To report similar clusters of Bcc with a majority of patients having positive urine cultures occurring since 2/1/2018 among non-cystic fibrosis patients to CDPHE, or for additional information, please contact Geoff Brousseau at 303-692-2766 or geoffrey.brousseau@state.co.us.
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