BEUDAMED
    FDA Recall Open, Classified

    MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

    Recall: Z-2595-2023 · Initiated August 3, 2023

    Recall

    Recall Number
    Z-2595-2023
    Event Number
    92881
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    JOK
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    August 3, 2023
    Posted
    September 18, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    MEDLINE STERILE IRIS SCISSORS CVD/STD, REF DYNJ04049

    Reason

    4.5" Iris Scissors, Sterile, Curved (DYNJ04049) are being recalled due to the potential of the tip protector to fall off. The sharp tip of the scissors could compromise the sterile barrier system by puncturing large and/or small holes that may not be visible to the user.

    Action

    Medline Industries issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem with the device, the potential hazard, and requested the following: Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. Distributors or those who resold or transferred the product were directed to notify their customers and have them destroy any affected product. If you have any questions, please contact the Recall Department at 866-359-1704.

    Distribution

    Worldwide distribution: US (nationwide) and OUS (foreign) countries of: Canada, Hong Kong, Taiwan, Singapore

    Quantity

    324,451 devices