BEUDAMED
    FDA Recall 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 · Initiated August 13, 2020

    Recall

    Recall Number
    Z-0309-2021
    Event Number
    86347
    Firm
    Battelle Memorial Institute
    FEI Number
    1523658
    Product Code
    QKY
    Status
    Terminated
    Root Cause
    Under Investigation by firm
    Initiated
    August 13, 2020
    Terminated
    February 3, 2021
    Address
    505 King Ave, Columbus, OH, 43201-2696

    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.

    Action

    Customers were notified via email on 8/13/20: Dear CCDSTM Customer, Recently, we became aware that masks processed at the Providence, RI CCDSTM site were not maintained at levels of condensation during a portion of the decontamination cycle. The first phase (gassing phase) operated as intended. The next phase (dwell phase) had a gradual decline of condensation. The CCDSTM team has corrected this and has confirmed that the system is operating correctly. The normal CCDSTM decontamination cycles operate above the levels of regulatory guidelines. To ensure that our process decontaminated the masks effectively, our research team replicated this process cycle, including the deviated dwell phase, with a similar number of masks in the chamber. As expected, the results showed a 6-log reduction. Though this was a deviation to an internal operating procedure, out of caution, we are asking you to return your masks to the CCDSTM site to be reprocessed. We will send you replacement masks if you need them while your masks are being decontaminated. Battelle CCDSTM is committed to maintaining the highest standards for our customers. Please contact us with any questions. Sincerely, Battelle CCDSTM Team Call us at 614-424-4373 [email protected]

    Distribution

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

    Quantity

    898