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Judul : Update #2: Burkholderia cepacia complex Infections Associated with Use of Medline Remedy Essentials No-Rinse Foam
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Update #2: Burkholderia cepacia complex Infections Associated with Use of Medline Remedy Essentials No-Rinse Foam

CDC continues to work with FDA and state and local health departments in affected states to investigate an outbreak of Burkholderia cepacia complex (Bcc) infections associated with Medline Remedy Essentials No-Rinse Foam. On May 8, 2018, Shadow Holdings dba Bocchi Laboratories, which manufactures the product, expanded their recall to include an additional lot of Medline Remedy Essentials No-Rinse Cleansing Foam. The voluntary recall now includes all lots beginning with the master batch numbers M05703, M06691, M07247 and M07476. The investigation to determine the underlying cause of contamination is ongoing.

Health care professionals and patients should discard all recalled lots of Remedy Essentials No-Rinse Cleansing Foam. Any hospital or company that purchased recalled Medline Remedy Essentials No-Rinse Cleansing Foam should immediately quarantine material under their control and contact Shadow Holdings dba Bocchi Laboratories. Patients, pharmacies, hospitals, and home health care facilities should immediately stop using and dispensing Medline Remedy Essentials No-Rinse Cleansing Foam with lot numbers: M05703, M06691, M07247, and M07476.

As of May 21, 2018, CDC reports that there are 15 confirmed cases of Bcc associated with the use of Medline Remedy Essentials No-Rinse Cleansing Foam (seven in California, one in New Jersey and seven in Pennsylvania). This cleansing foam is a product used for skin and perineal care. This product is used in hospitals and home-health settings for people who are unable to shower or bathe after surgery or due to other acute health conditions. 

A majority of patients involved in these clusters have had Bcc isolated from urine and were from patients without cystic-fibrosis. To report similar clusters occurring since 2/1/2018 to CDPHE, or for additional information, please contact Geoff Brousseau at 303-692-2766 or geoffrey.brousseau@state.co.us.
For more details about the recall, visit: https://www.fda.gov/Food/RecallsOutbreaksEmergencies/Outbreaks/ucm607082.htm 
For detailed product information, visit: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=164350

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