BEUDAMED
    FDA Enforcement Class II Terminated

    Aspirated Cyto-Histological Biopsy needle

    Recall: Z-2490-2021 · Reported September 29, 2021

    Enforcement

    Recall Number
    Z-2490-2021
    Event ID
    88430
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    M.D.L. S.r.l.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 29, 2021
    Initiation Date
    August 5, 2021
    Classification Date
    September 20, 2021
    Termination Date
    May 4, 2026
    Address
    Via Tavani N. 1/A, Delebio, N/A, Italy

    Description

    Aspirated Cyto-Histological Biopsy needle

    Reason

    Sterility assurance may be compromised.

    Code Info

    Model PB1810; Lot 1617A Model PB1815; Lots 5216C and 3620D Model PB1820; Lot 5216C Model PB1825; Lot 5216C Model PB2010; Lot 1617A Model PB2015; Lots 5216C, 2618B, and 3620D Model PB2020; Lots 5216C and 1618A Model PB2110; Lot 5216C Model PB2115; Lot 5216C Model PB2120; Lot 1617A Model PB2215; Lot 5216C Model PB2220; Lots 5216C, 1618A, 3620D Model PB2225; Lot 2518A

    Distribution

    Nationwide

    Quantity

    2750 devices