BEUDAMED
    FDA Recall Open, Classified

    Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851

    Recall: Z-1562-2026 · Initiated January 30, 2026

    Recall

    Recall Number
    Z-1562-2026
    Event Number
    98437
    FEI Number
    1417592
    Product Code
    OEZ
    Status
    Open, Classified
    Root Cause
    Error in labeling
    Initiated
    January 30, 2026
    Posted
    March 12, 2026
    Address
    3 Lakes Dr, Medline Industries, LP, Northfield, IL, 60093-2753

    Description

    Medline Kits containing Cardinal Health s Aqua-Seal Chest Drainage Unit: 1) OPEN HEART, Model Number: DYNJ902487A; 2) CARDIAC PROCEDURE, Model Number: DYNJ908126; 3) CARDIO CONGENITO, Model Number: DYNJ910851

    Reason

    The instructions for use (IFUs) on specified Cardinal Health Chest Drainage Units (CDUs) and accessories have been updated to clarify the intended target patient population as adults, 18 years and older.

    Action

    An URGENT MEDICAL DEVICE PRODUCT ADVISORY notification dated 1/30/25 was sent to customers. REQUIRED ACTION: 1.Actions to be taken are indicated on the attached recall notification from Cardinal Health. 2.Please use the link and the information below to complete your response form stating that you have received, read, understand and performed any actions as specified in the notification from CardinalHealth. Website link: https://recalls.medline.com Recall Reference #: R-26-006-FGX2 Recall Code: 3.If you are a distributor or have resold or transferred this product to another company or individual,you are required by FDA regulations to notify them of this communication. If you have any questions, contact the Recall Department at 866-359-1704 or [email protected].

    Distribution

    Worldwide - US Nationwide distribution in the state of CA and the countries of Chile, Panama.

    Quantity

    2894 units