Outbreak of B. cepacia Complex Linked to No-Rinse Cleansing Foam

The Center for Disease Control and Prevention (CDC) has reported at least 10 confirmed cases of bacterial infection of B. cepacia (within the Burkholderia cepacia complex) and have linked the infections to a hand soap foam cleanser by Medline.
The FDA has provided the following important facts:

  • The 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 at this time, as these products might be contaminated with several species within the bacteria, Burkholderia cepacia complex (Bcc).
  • Shadow Holdings dba Bocchi Laboratories has recalled certain lots of the product.
  • The FDA is investigating whether other products manufactured by Shadow Holdings dba Bocchi Laboratories may be contaminated with, Bcc, and may present a risk to consumers.
  • As of May 7, 2018, CDC reports that there are 10 confirmed cases of Bcc associated with use of Medline Remedy Essentials No-Rinse Cleansing Foam (seven in Pennsylvania, one in New Jersey and two in California). These patients were already hospitalized for acute conditions and acquired the infections while hospitalized.
  • This cleansing foam is a product used for skin and perineal care. It is used in hospitals and home-health care settings for people who are unable to shower or bathe after surgery or due to other acute health conditions. FDA is particularly concerned about contamination in this product, since product instructions do not include rinsing the product from patient skin. This poses a risk to persons who might be immunocompromised or have other underlying medical conditions.
  • State and federal health officials have collected samples of the product from multiple locations, including affected hospitals. As of May 7, 2018, there have been multiple product samples that tested positive for Bcc. Isolates from these product samples match clinical strains isolated from case patients by Pulsed Field Gel Electrophoresis (PFGE). Additionally, an environmental swab collected at Shadow Holdings, dba Bocchi Laboratories during FDA’s investigation has tested positive for a strain of Bcc. Given these positive samples, the FDA is advising the public to not use any Medline Remedy Essentials No-Rinse Cleansing Foam products at this time.
  • The FDA will update the public with more information as it becomes available.

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