BEUDAMED
    FDA Recall Open, Classified

    These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES: a) MSC351400AN/Z (7 X 8 , 150 ct canister), b) MSC351410AN/Z (6 x 5 , 150ct canister), c) MSC3560012 (private-labeled 6 x 5 , 150ct canister), d) MSC351450AN (12" x 12", 110ct bucket), e) MSC351450BG4 (12" x 12", 110ct bag)

    Recall: Z-1180-2024 · Initiated December 20, 2023

    Recall

    Recall Number
    Z-1180-2024
    Event Number
    93745
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    LRJ
    Status
    Open, Classified
    Root Cause
    Process control
    Initiated
    December 20, 2023
    Posted
    February 22, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    These wipes are saturated with 0.65% bleach solution. These wipes are antimicrobial, disinfectant with sporicidal, virucidal, bactericidal, and fungicidal activites. MEDLINE MICRO-KILL Bleach GERMICIDAL BLEACH WIPES: a) MSC351400AN/Z (7 X 8 , 150 ct canister), b) MSC351410AN/Z (6 x 5 , 150ct canister), c) MSC3560012 (private-labeled 6 x 5 , 150ct canister), d) MSC351450AN (12" x 12", 110ct bucket), e) MSC351450BG4 (12" x 12", 110ct bag)

    Reason

    There is stability concern for products dated with a 24-month shelf life. Product is safe and effective up to 12 months shelf life.

    Action

    Medline Industries, LP issued an IMMEDIATE ACTION REQUIRED notice to it consignees on 12/20/2023 via USPS first class mail. The notice explained the problem with the device and requested that the consignee destroy all affected product. Any parties to whom the product was transferred must be notified of the recall communication. For questions, please contact 866-359-1704.

    Distribution

    US and territories, S. Korea, Panama, and Dubai

    Quantity

    1,314,719 units