BEUDAMED
    FDA Recall Open, Classified

    Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000

    Recall: Z-2206-2023 · Initiated May 12, 2023

    Recall

    Recall Number
    Z-2206-2023
    Event Number
    92412
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    HRR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 12, 2023
    Posted
    July 20, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline O.R. Scissors, S/B, Sterile, 5.5, Model #DYND04000

    Reason

    The scissors were manufactured without a tip protector resulting in the scissors breaking through the semi-rigid plastic tray compromising sterility.

    Action

    The recalling firm issued letters dated 5/12/2023 via first class mail and email on 5/12/2023. The letter explained the reason for recall and provided the required actions. The actions were to immediately check their inventory for the affected item number and lot numbers listed on the recalling firm's recall portal and destroy the products. A website link is provided for completing the response form and for obtaining the specific item and lot numbers affected. Once the response form is submitted, the consignee account will be credited. Distributors are instructed to notify the customers of the recall who have received the affected product and the customer is to document the destruction of their product. The distributor is to include the customer product quantities in their response form.

    Distribution

    US Nationwide distribution. There was government distribution but no military or foreign distribution.

    Quantity

    189,221 scissors