An outbreak of Burkholderia cepacia complex (Bcc) infections associated with the use of Medline Remedy Essentials No-Rinse Cleansing Foam has expanded to included 15 people in three states, up from the 10 cases reported on May 7. A recall has been issued for the product which is manufactured by Shadow Holdings dba Bocchi Laboratories based in Santa Clarita, CA.
The recalled product is used in hospitals and home-healthcare settings to clean the skin and perineal area of patients who are unable to shower or bathe due to health conditions or are recovering from surgery. So all of the case-patients sickened in this outbreak were hospitalized for other acute conditions when they were exposed to the product. The outbreak now includes seven patients in Pennsylvania, seven patients in California and one patient in New Jersey, according to the latest update from the Centers for Disease Control and Prevention (CDC).
The U.S. Food and Drug Administration (FDA) continues to advise consumers and healthcare facilities not to use this product at this time and is investigating whether other products made by Shadow Holdings may also be contaminated. Results from tests on samples of the product collected from multiple locations, including affected hospitals, showed multiple product samples were contaminated with Bcc. Isolates of the bacteria from those found in case-patients matched those found in samples of the product and in an environmental swab collected from the Shaw Holdings facility where the product was manufactured.
Bcc bacteria can grow in aqueous environments and exhibit resistance to preservatives and antibiotics. People suffering from a Bcc infection may experience serious respiratory problems or they may not show any symptoms at all. Those most at risk of infection include people with weakened immune systems, chronic lung diseases and wound infections.
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