A multistate outbreak of Burkholderia cepacia complex (Bcc) has been reported by the Centers for Disease Control and Prevention (CDC). As of May 7, 2018, CDC reports that there are 10 confirmed cases of 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 has prompted the Food and Drug Administration (FDA) to advise 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.
In addition, a recall of the product was issued. On March 28, 2018, Shadow Holdings dba Bocchi Laboratories of Santa Clarita, CA, announced a voluntary recallof 4oz and 8oz bottles of Medline Remedy Essentials No-Rinse Cleansing Foam lots that had been identified as positive for B. cepacia, including lot numbers: M05703, M06691, and M07247. The FDA is currently investigating this matter further to determine whether any additional products or lots may present a risk to consumers.
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 effects of B. cepacia infection on people vary widely, ranging from no symptoms at all to life-threatening infections. Strains of B. cepacia bacteria are often resistant to common antibiotics. Transmission of B. cepacia from contaminated medicines and devices has been reported. B. cepacia can also be spread to susceptible persons by: person-to-person contact, contact with contaminated surfaces, or exposure to B. cepacia in the environment. The incubation period varies.