Update May 21, 2018
CDC is collaborating with the Food and Drug Administration (FDA), state and local health departments, and healthcare facilities to investigate a recent outbreak of Burkholderia cepacia complex (Bcc) infections. As of May 21, 2018, CDC confirmed 15 cases of Bcc infections associated with use of Medline (Northfield, IL) Remedy Essentials No-Rinse Cleansing Foam. Seven infections were in patients in Pennsylvania, seven were in California, and one was in New Jersey. These patients were already hospitalized for acute conditions and acquired the infections while hospitalized.
As of May 8, 2018 FDA is advising health professionals and consumers to avoid using all lots of Medline Remedy Essentials No-Rinse Cleansing foam, manufactured by Shadow Holdings dba Bocchi Laboratories (Santa Clarita, CA), as these products might be contaminated with Bcc. Shadow Holdings dba Bocchi Laboratories has recalled certain lots of the product.
The FDA is investigating this matter further to determine whether any additional products or lots may present a risk to consumers.
B. cepacia complex bacteria are environmental pathogens. Infections can be transmitted through infection control lapses, including indirect contact via environmental surfaces. Person-to-person transmission is possible but less common. B. cepacia complex bacteria can grow in aqueous environments, can exhibit resistance to preservatives, and can cause contamination of liquid medications or other liquid products. These factors have led to previous healthcare-associated outbreaks of B. cepacia complex. For additional information on B. cepacia complex bacteria please visit: Burkholderia cepacia in Healthcare Settings(https://www.cdc.gov/hai/organisms/bcepacia.html).
Report adverse reactions or quality problems experienced with the use of this product to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
The product recall notice and list of products can be found here: Medline Canada, Corp. recalls Remedy Essentials Foaming Cleanser
Additional updates will be posted as they become available.