BEUDAMED
    FDA Recall Open, Classified

    CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760

    Recall: Z-1015-2023 · Initiated December 23, 2022

    Recall

    Recall Number
    Z-1015-2023
    Event Number
    91420
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    OXQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 23, 2022
    Posted
    January 25, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    CENTURION MEDICAL PRODUCTS, SILVER ANTIMICROBIAL VAD DRIVE, REF DT18760

    Reason

    The kit contained an expired component.

    Action

    Medline Industries issued a DEVICE RECALL notice to its consignees on 12/23/2022 by First Class Mail. The notice explained the problem and requested the following: "REQUIRED ACTION: -Immediately check your stock for the affected item number and the affected lot numbers listed on the recall portal. Destroy affected product. -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 document and destroy any affected product. You should include your customers quantities on your response form. If you have any questions, please contact the Recall Department at 866-359-1704."

    Distribution

    US Nationwide distribution in the states of NY, IN, FL, NJ, IL.

    Quantity

    1050 kits