BEUDAMED
    FDA Enforcement Class II Terminated

    Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.

    Recall: Z-1548-2021 · Reported May 19, 2021

    Enforcement

    Recall Number
    Z-1548-2021
    Event ID
    87635
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atos Medical AB
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    May 19, 2021
    Initiation Date
    March 29, 2021
    Classification Date
    May 10, 2021
    Termination Date
    February 17, 2022
    Address
    Kraftgatan 8, Horby, N/A, Sweden

    Description

    Provox Life Night HME, Catalogue Number 8262 - Product Usage: single use heat and moisture exchangers for patients breathing through a tracheostoma.

    Reason

    Provox Life Night HME may be incorrectly inserted sideways or forcefully through the adhesive coupling potentially occluding or blocking the stoma.

    Code Info

    Lot Numbers: 2012158 and 2012124

    Distribution

    US Nationwide distribution in the states of IL, CT, VA, NM, NY, SC, NJ, OK, MN, MI, NC, OH, AZ, WI, CA, PA, ID.

    Quantity

    225 boxes of 30 devices