BEUDAMED
    FDA Recall 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 · Initiated December 12, 2016

    Recall

    Recall Number
    Z-0984-2017
    Event Number
    75948
    Firm
    MEDLINE IND
    FEI Number
    1417592
    Product Code
    KMJ
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    December 12, 2016
    Terminated
    June 27, 2019
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    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.

    Action

    Medline Industries sent a recall notification letters dated December 12, 2016 to customers. The letter identified the affected product, problem and actions to be taken. Customers were instructed to quarantine any affected product on hand and return product to Medline Industries for credit. Distributors were instructed to notify their customers and have them return affected product as well. For questions contact 866-359-1704.

    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