BEUDAMED
    FDA Enforcement Class II Terminated

    Centurion- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STERILE KIT 3703ST STERILE PATHOLOGY CONTAINER 3706ST STERILE CONTAINER 165 OZ.

    Recall: Z-1067-2020 · Reported February 12, 2020

    Enforcement

    Recall Number
    Z-1067-2020
    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- Pathology Container 1150ST STERILE GRADUATED CONTAINER, 32 OZ. 17070 AI OR CARDIAC STERILE KIT 3703ST STERILE PATHOLOGY CONTAINER 3706ST STERILE CONTAINER 165 OZ.

    Reason

    Incomplete seals on the sterile package may compromise the sterility

    Code Info

    1150ST STERILE GRADUATED CONTAINER, 32 OZ. 2018110690 17070 AI OR CARDIAC STERILE KIT 2018121490 3703ST STERILE PATHOLOGY CONTAINER 2019031990 3706ST STERILE CONTAINER 165 OZ. 2019041290

    Distribution

    Nationwide Foreign: GHANA

    Quantity

    N/A