BEUDAMED
    FDA Enforcement Class II Ongoing

    (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.

    Recall: Z-0532-2025 · Reported December 4, 2024

    Enforcement

    Recall Number
    Z-0532-2025
    Event ID
    95638
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 4, 2024
    Initiation Date
    October 15, 2024
    Classification Date
    November 25, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753, United States

    Description

    (1) Medline Open Heart CDS, REF CDS840132O, packaged 1 kit/case, non-sterile; and (2) Medline Dr. Davies CV, REF DYNJ903016G, packaged 1 kit/case, non-sterile.

    Reason

    Some of the suture packages within the convenience kits contain the incorrect needle type/size and suture diameter/length.

    Code Info

    (1) REF CDS840132O - Lot number 24BBF701, exp. 10/31/2024, UDI-DI each 10195327245276, UDI-DI case 40195327245277; (2) REF DYNJ903016G - Lot numbers 24DBP801, exp. 8/31/2025; and 24CBJ749, exp. 11/30/2024, UDI-DI each - 10195327657154, UDI-DI case - 40195327657155.

    Distribution

    US Nationwide distribution in the states of AL, GA, MA, NJ, and PA.

    Quantity

    408 kits