Seven patients in Pennsylvania hospitals and one in New Jersey have contracted potentially serious infections after the use of a cleansing foam, U.S. government officials said.
The product, Medline Remedy Essentials No-Rinse Foam, was voluntarily recalled on March 28 by its manufacturer, Santa Clarita, Calif.-based Shadow Holdings, which does business as Bocchi Labs, according to the Food and Drug Administration.
The infection, which also was identified in seven California patients, was caused by bacteria called Burkholderia cepacia. This microbe poses little risk to healthy people but can cause serious respiratory infections in those with weakened immune systems or chronic lung disease, the U.S. Centers for Disease Control and Prevention said.
Pennsylvania Department of Health officials declined to reveal any information about the patients or hospitals, citing the potential for violating the patients’ privacy. An agency spokesperson declined even to say in what part or parts of the state the infections were identified.
The 15 infected patients already were hospitalized for acute conditions and became infected while in the facilities, the CDC said.
The no-rinse foam is used in hospitals and home health-care settings to clean the skin of patients who cannot shower or bathe because they are recovering from surgery or an illness, the FDA said.
State and federal officials have collected samples of the foam from multiple locations, including the affected hospitals. The strain of bacteria identified in the foam samples was the same as that found in patients, the FDA said.
The FDA also has collected bacterial samples at the manufacturing facility and is investigating whether additional batches of the cleanser may contain the bacteria that caused the infection.
Bocchi Labs, which makes this and other personal-care products on a contract basis, did not respond to a request for comment. Medline, which markets the cleanser, said it was aware of only 10 cases of infection, and that none had led to serious illness.
Contamination was found in three “lots” of cleanser made at a Bocchi facility between August and October 2017, Medline said. As a precaution, the company said it has recalled additional lots in which no contamination was found, and has temporarily halted additional shipments.