BEUDAMED
    FDA Enforcement Class II Terminated

    Revanesse Versa, PN40081

    Recall: Z-1146-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1146-2020
    Event ID
    83834
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Prollenium Medical Technologies Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    February 19, 2020
    Initiation Date
    November 15, 2018
    Classification Date
    February 10, 2020
    Termination Date
    March 22, 2024
    Address
    138 Industrial Pky N, Aurora, N/A, Canada

    Description

    Revanesse Versa, PN40081

    Reason

    Labeling error. The product is labeled with an 18 month expiration date, however the product is approved for 12 months.

    Code Info

    Lot #/ Exp. date 17K004/July 31, 2018 17K005/July31,2018 I7K006/August 31, 2018 17K007/August 31, 2018 17K090/October 31, 2018 17K091/October 31, 2018 17L026/October 31, 2018 17L028/October 31, 2018 I7L050/November 30, 2018 17L0S1/November 30, 2018 18A023/November 30, 2018 18A024/November 30, 2018 I8E028/December 31, 2018 18E029/December 31, 2018 18F032/December 31, 2018 18F033/December 31, 2018 18G065/April 30, 2019 18G074/April 30, 2019 18G075/April 30, 2019 18G076/April 30, 2019 181022/June 30, 2019 181029/June 30, 2019

    Distribution

    US Nationwide distribution TX, FL, NC, LA, KY, WI, SD, IL, KS, CA

    Quantity

    48,457 kits