FDA-Device2020-11-04Class II
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.
Battelle Memorial Institute
Hazard
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
Sold states
US Nationwide distribution including in the states of CT, MA, RI.
Affected count
898
Manufactured in
505 King Ave, N/A, Columbus, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0309-2021Don't want to check this manually?
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