BEUDAMED
    FDA Recall 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 · Initiated November 5, 2020

    Recall

    Recall Number
    Z-0615-2021
    Event Number
    86764
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    NAB
    Status
    Terminated
    Root Cause
    Packaging
    Initiated
    November 5, 2020
    Terminated
    August 4, 2021
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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.

    Action

    Medline Industries, Inc. notified all affected consignees via first class mail on November 5, 2020 with a letter titled, "URGENT RECALL NOTIFICATION MEDLINE INDUSTRIES, INC. IMMEDIATE ACTION REQUIRED." Customers will be responsible for initiating sub-recall procedures. The required action's mentioned in the recall notification letter include: "1. Immediately check your stock for the affected item number and the affected lot numbers listed on the attachment. Quarantine all affected product. 2. Please return the completed enclosed response form listing the quantity of affected product on hand. Even if you do not have any affected product please complete and return the form, as indicated on the response form. When we receive your completed response form you will be sent return labels (if applicable). Your account will receive credit when the returned product is received. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. Have the customers return any affected product to you for collection and return to Medline Industries, Inc."

    Distribution

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

    Quantity

    15,780