BEUDAMED
    FDA Recall Open, Classified

    MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes

    Recall: Z-0696-2022 · Initiated December 29, 2021

    Recall

    Recall Number
    Z-0696-2022
    Event Number
    89440
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LRJ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    December 29, 2021
    Posted
    March 1, 2022
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    MEDLINE Micro-Kill Bleach Germicidal Bleach Wipes

    Reason

    Micro-Kill Bleach Wipes contain out of specification (low) levels of Sodium Hypochlorite.

    Action

    The firm initiated the recall on January 13, 2022 and provided each consignee with a letter and a response form to record their response to the recall notification. Each response received will be recorded and the firm will send subsequent letters to consignees that have not provided a response to the recall notification in the allotted time. The letter explained the issue and requested return of the product, if available. Customers will be responsible for initiating sub-recall procedures. Any recalled product that is returned from customers will be quarantined at the firm's corporate office pending destruction. The firm expanded the original recall notification dated January 13, 2022 to include additional lots of the Micro-Kill Bleach Germicidal Bleach Wipes due to product not meeting label claim for Sodium Hypochlorite content. A letter was sent out to all consignees within the scope of the expanded recall on 02/25/2022 with the same instructions. The firm sent a letter dated July 27, 2022, to previous non-responding consignees instructing them to destroy any affected product per their local and state regulations and document the destruction.

    Distribution

    Worldwide distribution - US Nationwide and the countries of Panama and Bermuda.

    Quantity

    359,524 units