BEUDAMED
    FDA Enforcement Class II Terminated

    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.

    Recall: Z-0309-2021 · Reported November 4, 2020

    Enforcement

    Recall Number
    Z-0309-2021
    Event ID
    86347
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Battelle Memorial Institute
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 4, 2020
    Initiation Date
    August 13, 2020
    Classification Date
    October 29, 2020
    Termination Date
    February 3, 2021
    Address
    505 King Ave, N/A, Columbus, OH, 43201-2696, United States

    Description

    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.

    Reason

    Masks processed at one site were not maintained at levels of condensation during a portion of the decontamination cycle.

    Code Info

    All decontaminated compatible N95 respirators distributed from Providence, RI between 07/01/2020 and 08/12/2020.

    Distribution

    US Nationwide distribution including in the states of CT, MA, RI.

    Quantity

    898