BEUDAMED
    FDA Enforcement Class II Terminated

    RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.

    Recall: Z-0615-2021 · Reported December 23, 2020

    Enforcement

    Recall Number
    Z-0615-2021
    Event ID
    86764
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 23, 2020
    Initiation Date
    November 5, 2020
    Classification Date
    December 17, 2020
    Termination Date
    August 4, 2021
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    RevMedX Trauma Dressings are packaged in a Tyvek Peel pouch, 1 Trauma Dressing per Tyvec Peel Pouch, 30 Pouches per Case; Sterile - Product Usage: are intended to absorb exudates.

    Reason

    RevMedX Trauma Dressing is being recalled due to package seal integrity.

    Code Info

    Item Number: NONEX15182W Lot Number/Expiration Date: 38217080001, 08/2022; 38217080002, 08/2022; 38217070001, 07/2022; and 38218050002, 05/2023

    Distribution

    Worldwide distribution - US Nationwide distributions and the countries of Singapore, Denmark, Poland, Portugal, Kenya, Israel, and France.

    Quantity

    15,780