BEUDAMED
    FDA Enforcement Class II Terminated

    Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19

    Recall: Z-2490-2020 · Reported July 15, 2020

    Enforcement

    Recall Number
    Z-2490-2020
    Event ID
    85776
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Prodimed Plastimed Division
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
    Report Date
    July 15, 2020
    Initiation Date
    May 27, 2020
    Classification Date
    July 4, 2020
    Termination Date
    March 29, 2021
    Address
    3 Rue Louis Armand, Le Plessis Bouchard, N/A, France

    Description

    Prodimed Combicath catheters for blind or fibrescope-guided protected distal bronchial sampling (PDBS)- COMBICATH PE 90 cm Product Code: 58229 19

    Reason

    Lack of assurance of sterility

    Code Info

    All lots within expiry

    Distribution

    Nationwide

    Quantity

    1460