BEUDAMED
    FDA Enforcement Class II Terminated

    Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955

    Recall: Z-0344-2020 · Reported November 13, 2019

    Enforcement

    Recall Number
    Z-0344-2020
    Event ID
    84165
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Centurion Medical Products Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    November 13, 2019
    Initiation Date
    October 24, 2019
    Classification Date
    November 6, 2019
    Termination Date
    June 24, 2020
    Address
    100 Centurion Way, N/A, Williamston, MI, 48895-9086, United States

    Description

    Centurion Medical Products UNIVERSAL LINE FULL BODY DRAPE KIT - REG Code: DT11955

    Reason

    Sterile packaging incomplete seals may compromise sterility of the product

    Code Info

    Lot/Batch Number: 2019052190 Exp Date: 5/31/2024

    Distribution

    Nationwide

    Quantity

    80 units