BEUDAMED
    FDA Enforcement Class II Terminated

    11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK

    Recall: Z-1644-2021 · Reported May 26, 2021

    Enforcement

    Recall Number
    Z-1644-2021
    Event ID
    87696
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    BIOPSYBELL S.R.L.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 26, 2021
    Initiation Date
    March 22, 2021
    Classification Date
    May 19, 2021
    Termination Date
    February 17, 2026
    Address
    Via Aldo Manuzio N. 24, Via A.Manuzio n.24, Mirandola, N/A, N/A, Italy

    Description

    11G DIRECT SINGLE - ACCESS, CODE INTVMN-DSBAK

    Reason

    Products labeled as sterile were distributed, but may not have been sterilized.

    Code Info

    LOT: 20051162

    Distribution

    US Nationwide distribution in the states MS and KY.

    Quantity

    50 units