BEUDAMED
    FDA Recall Open, Classified

    MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592

    Recall: Z-0122-2023 · Initiated September 9, 2022

    Recall

    Recall Number
    Z-0122-2023
    Event Number
    90911
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LRO
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    September 9, 2022
    Posted
    October 21, 2022
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    MEDLINE BLOOD CLUTURE KIT, Reorder #: DYNDH1592

    Reason

    Adult Blood Culture Collect kit and Pre-Op Changing Bathing Kit contain an incorrect expiration date on a component with the kit. CHG Solution with the Pre-Op Changing Bathing Kit and Bactec bottle plastic both have an expiration date that does not match the date listed on the kit.

    Action

    Medline disseminated a recall notice titled "IMMEDIATE ACTION REQUIRED" by US mail and email on 09/16/2022and 09/23/2022. The notice requested the following: "REQUIRED ACTION: 1. Immediately check your stock for Kit Number and Kit Lot Number, listed on the destruction form, quarantine all affected product. Destroy all product belonging to the affected lot numbers listed on the destruction form. 2. Please return the completed enclosed destruction form listing the quantity of affected product destroyed. Even if you do not have any affected product please complete and return the form, as indicated on the destruction form. When we receive your completed destruction form your account will be issued a credit, if applicable. 3. If you have transferred possession of this product to another individual, to another department or another location in your organization you are required by FDA regulations to notify them of this recall communication. If you have any questions, please contact 866-359-1704."

    Distribution

    US Nationwide distribution in the state of California.

    Quantity

    1600 kits