A recall and consumer advisory have been issued for all lots of Medline Remedy Essentials No-Rinse Cleansing Foam after an outbreak of Burkholderia cepacia complex (Bcc) has been linked to its use. The no-rinse cleansing foam, manufactured by Shadow Holdings dba Bocchi Laboratories, is used in hospitals and home-health care 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.
Ten people hospitalized for acute conditions in three states contracted Bcc infections after exposure to this product. Seven of the cases were reported in Pennsylvania, two in California and one in New Jersey.
The U.S. Food and Drug Administration (FDA) is advising consumers and healthcare facilities not to use this product at this time The agency has tested samples of the product collected from multiple locations including affected hospitals. Results showed multiple product samples were contaminated with Bcc. Isolates of the bacteria matching those found in case-patients were found in samples of the product and in an environmental swab collected from the Shaw Holdings facility where the product was manufactured.
Shadow Holdings issued a voluntary recall of 4 oz and 8 oz bottles of the product with lot numbers M05703, M06691, and M07247 on March 28. The FDA, which is advising that no lots of this product be used, is investigating if other products manufactured by this company may also pose a risk to consumers. The agency is asking hospitals to quarantine the material and advising healthcare professionals and consumers who have the product to discard it.
About B. cepacia
People suffering from a B. cepacia infection may show no symptoms or they may experience serious respiratory problems. Those most at risk of suffering serious symptoms include people with weakened immune systems, chronic lung diseases and wound infections. B. cepacia is often resistant to common antibiotics.
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