BEUDAMED
    FDA Enforcement Class II Terminated

    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

    Recall: Z-0984-2017 · Reported January 18, 2017

    Enforcement

    Recall Number
    Z-0984-2017
    Event ID
    75948
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    MEDLINE IND
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    January 18, 2017
    Initiation Date
    December 12, 2016
    Classification Date
    January 9, 2017
    Termination Date
    June 27, 2019
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    Medline E-Z Lubricating Jelly; Bacteriostatic. Water Soluble. Sterile. 2 FL OZ (59 ml). Product Usage: For medical purposes to lubricate body orifices to facilitate entry of diagnostic or therapeutic devices. Single use only. Sterile if unopened, undamaged package.

    Reason

    Product was not sterilized. Product was shipped to distribution centers instead of the sterilization facility due to an operations error by a 3rd party shipping company.

    Code Info

    Lot Numbers: 6I26; Unit No: MDS032285; Expiration Date: 08/2019

    Distribution

    Worldwide Distribution - US Nationwide in the states of AL, FL, GA, IA, IL, IN LA, MI, PA, TX, WI, and the country of Canada

    Quantity

    12,024 tubes