BEUDAMED
    FDA Recall Open, Classified

    RUMMELL, Medline Item No. ST006ST

    Recall: Z-0760-2025 · Initiated November 12, 2024

    Recall

    Recall Number
    Z-0760-2025
    Event Number
    95843
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LRP
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    November 12, 2024
    Posted
    December 23, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    RUMMELL, Medline Item No. ST006ST

    Reason

    Weak seals may result in a breach of sterility, which may not be detectable to the user. This can lead to increased risk of contamination and infection.

    Action

    On November 25, 2024, the firm notified customers via letters titled IMMEDIATE ACTION REQUIRED. Customers were informed that specific items and lots of Pure Pouch Single-Sterile and Sterile Kits are being recalled due to weak seals. Affected product must be destroyed. The letter included instructions on actions to take to be issued a credit. Customers should immediately check their stock for affected product and quarantine all units. Affected lots should be destroyed. When the recalling firm has received your completed destruction form, your account will be issued a credit, if applicable. If you have any questions, please contact 866-359-1704.

    Distribution

    US Nationwide distribution.

    Quantity

    21,440 total