BEUDAMED
    FDA Recall Open, Classified

    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470

    Recall: Z-1115-2023 · Initiated December 7, 2022

    Recall

    Recall Number
    Z-1115-2023
    Event Number
    91483
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    OGR
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 7, 2022
    Posted
    February 10, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Surgical convenience kits labeled as: CENTURION MEDICAL PRODUCTS TRACHEOSTOMY TRAY, Reorder Number TC7470

    Reason

    The recall is due to the perforated bag not allowing for outside of the kit wrapping to be sterile, therefore, only the contents inside the kits wrapping are sterile.

    Action

    The firm sent a correction notice to its direct consignees on 12/07/2022 by US mail and email. The notice explained the issue and requested the following: "Please check you stock for affected kits and over-labeling will be sent to place on kits to ensure that all labeling is accurate. No kits are to be returned back to Medline. All components are not affected. Our records indicate that these were used as a component in the list of kit(s) purchased from Medline Industries, LP." "If you are a distributor, or have resold or transferred this product to another company or individual, 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, LP." "If you have any questions, please contact the Recall Department at 866-359-1704."

    Distribution

    Nationwide

    Quantity

    120 units