BEUDAMED
    FDA Recall Open, Classified

    Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray

    Recall: Z-1041-2025 · Initiated November 18, 2024

    Recall

    Recall Number
    Z-1041-2025
    Event Number
    96110
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LRP
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 18, 2024
    Posted
    January 28, 2025
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline procedure kits labeled as: 1) SHORT TERM INFUSAPORT ACCESS KIT, Reorder number DYNDC3188; surgery tray

    Reason

    Certain Medline kits were manufactured and distributed with Procedure Masks with SO SOFT Earloops, and SOFT TOUCH II Surgical Masks which were subsequently recalled for not meeting the bioburden testing requirements of EN 14683.

    Action

    Medline issued a MEDICAL DEVICE RECALL notice to its consignees on 11/18/2024 via USPS and email. The notice explained the reason for the recall and requested quarantine of affected products pending correction. The firm requested the completion of the response form, which upon receipt, Medline will send labels to affix to the affected products with the instructions for the consignee to remove the affected component prior to using the kit.

    Distribution

    US Nationwide distribution.

    Quantity

    1450 units