Battelle Memorial Institute recalls Critical Care Decontamination System (CCDS) Compatible N95
Recalled Product
Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compatible N95 respirators2 for multiple-user3 reuse by healthcare personnel (HCP)4 to prevent exposure to pathogenic biological airborne particulates when there are insufficient supplies of Filtering Facepiece Respirators (FFRs) resulting from the Coronavirus Disease 2019 (COVID-19) pandemic.
Hazard / Issue
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Issued by
FDA
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