BEUDAMED
    FDA Recall Open, Classified

    STERILE PVP SLN KIT, REF DYNDM1097

    Recall: Z-0526-2024 · Initiated November 3, 2023

    Recall

    Recall Number
    Z-0526-2024
    Event Number
    93395
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    November 3, 2023
    Posted
    December 11, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    STERILE PVP SLN KIT, REF DYNDM1097

    Reason

    The product description on the labeling includes the word "Sterile" or STRL", however the contents of the solution inside the foil sachet is non-sterile.

    Action

    Medline Industries notified its consignees on 11/03/2023 via by email and US Mail (first class). The notice explained the issue and requested the destruction of any affected inventory. Distributor were directed to notify their customers.

    Distribution

    US Nationwide distribution in the states of CT, IA, LA, MA, PA, CA, NY, FL.

    Quantity

    100 units