Medline Remedy Essentials No-Rinse Cleansing Foam Linked To B. Cepacia Outbreak: FDA
Federal health officials indicate that at least 10 reports have been received involving hospital patients contracting Burkholderia cepacia infections after exposure to MedLine Remedy Essentials cleaning foams.
A MedLine Remedy Essentials No-Rinse Cleansing Foam recall was announced by the FDA on May 8, after random sample testing confirmed the presence of bacteria similar or identical to those collected from sickened patients. The products were manufactured by Shadow Holdings, doing business as Bocchi Laboratories.
The foam products are heavily used in home-health and hospital settings for skin and perineal care, providing a way to clean individuals who are unable to shower or bathe after surgery or due to other conditions.
Burkholderia cepacia is a group of complex bacteria that can be found in soil and water and are often resistant to many common antibiotics. Although the bacterial infection poses no significant threat to healthy individuals, those with respiratory infections, specifically cystic fibrosis and chronic lung disease may be more susceptible to the bacteria and require immediate medical treatment. They also pose an increased risk to those with weakened immune systems such as children and the elderly.
According to the recall, FDA officials have confirmed 10 infections associated with the use of the cleansing products. They include seven cases from Pennsylvania, two from California and one from New Jersey.
All of those who have become sick with B. cepacia infections were in hospital settings and used Medline Remedy Essentials No-Rinse Cleansing Foam products.
After learning of the reported cases, both state and federal officials began collecting swabs from sickened patients and determined the strain of the infections were closely related. The FDA also collected environmental swabs at the manufacturer’s production plant, which tested positive for a strain of B. cepacia. After further testing and comparing strains of B. cepacia collected at the manufacturing plant to those sickened, the FDA determined the cleansing solutions were the source of the contamination.
The products were manufactured by Bocchi Laboratories of Santa Clarita, California. They were sold and distributed to hospitals, medical centers, and various other retailers throughout the United States.
The FDA is advising health professionals and consumers to avoid using all Medline Remedy Essentials No-Rinse Cleansing Foam products at this time to avoid severe infections. Healthcare facilities and patients are being instructed to discard all of the recalled cleansing foam products.
Hospitals with the recalled products in their inventory should quarantine the products and contact Shadow Holdings dba Bocchi Laboratories.