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Battelle Memorial Institute recalls Critical Care Decontamination System (CCDS) Compatible N95 respirators - Product Usage: Used in decontaminating compat
Recalled November 4, 2020 · FDA recall Z-0309-2021 · Battelle Memorial Institute
Hazard
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle. · FDA Class II
Units
898
Sold at
US Nationwide distribution including in the states of CT, MA, RI.
Description
Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.
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.
Manufacturer(s)
Battelle Memorial Institute
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →