BEUDAMED
    FDA Enforcement Class II Terminated

    Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1109 TRAY,CIRCUMCISION DYNDF1128 CIRCUMCISION TRAY

    Recall: Z-1051-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1051-2020
    Event ID
    84530
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 12, 2020
    Initiation Date
    December 11, 2019
    Classification Date
    February 5, 2020
    Termination Date
    September 4, 2020
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    Centurion- Circumcision Tray Kits DYNDF1078C CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1082 CIRCUMCISION TRAY DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP DYNDF1109 TRAY,CIRCUMCISION DYNDF1128 CIRCUMCISION TRAY

    Reason

    Incomplete seals on the sterile package may compromise the sterility

    Code Info

    Lot Numbers: DYNDF1078C CIRCUMCISION TRAY 2019051390 DYNDF1082 CIRCUMCISION TRAY 2019011590 DYNDF1082 CIRCUMCISION TRAY 2018121490 DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP 2019051490 DYNDF1093C UNIVERSAL CIRCUMCISION TRAY W/O CLAMP 2018111490 DYNDF1109 TRAY,CIRCUMCISION 2019020690 DYNDF1128 CIRCUMCISION TRAY 2018121490

    Distribution

    Nationwide Foreign: GHANA

    Quantity

    N/A