BEUDAMED
    FDA Recall 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 · Initiated March 29, 2021

    Recall

    Recall Number
    Z-1548-2021
    Event Number
    87635
    Firm
    Atos Medical AB Kraftgatan
    FEI Number
    3002806269
    Product Code
    BYD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    March 29, 2021
    Terminated
    February 17, 2022
    Address
    8 Horby 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.

    Action

    Atos Medical initiated the recall by telephone and email on 03/29/2021 to the medical facilities. The firm followed with a letter mailed (USPS) on 04/01/2021. The firm will begin contacting the patients the week of April 5, 2021 to confirm receipt of the letter, confirm understanding of the correct use, and answer any questions.

    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