BEUDAMED
    FDA Recall Terminated

    MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8

    Recall: Z-0112-2018 · Initiated October 10, 2017

    Recall

    Recall Number
    Z-0112-2018
    Event Number
    78319
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    BSY
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    October 10, 2017
    Posted
    November 18, 2017
    Terminated
    August 4, 2020
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    MEDLINE PEDI ELBOW CLOSED SUCTION CATHETER, 8Fr, REF DYNCPE8

    Reason

    Products labeled as sterile were distributed prior to sterilization

    Action

    The recall was initiated by mail on 10/10/2017. The letter contained the following directive: "REQUIRED ACTION: 1. Immediately check your stock for item numbers DYNCPE8 (Lot 2861707008) & DYNCSDS12 (Lot 28617070015) place them on hold and complete the attached response form. Quarantine all affected product / lots. 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. If you have any questions, please contact 866-359-1704."

    Distribution

    FL, IN, TN, GA, NJ, UT, MD, Nicaragua, Honduras

    Quantity

    190 units