BEUDAMED
    FDA Recall Open, Classified

    Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

    Recall: Z-0484-2024 · Initiated September 29, 2023

    Recall

    Recall Number
    Z-0484-2024
    Event Number
    93408
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    GBZ
    Status
    Open, Classified
    Root Cause
    Nonconforming Material/Component
    Initiated
    September 29, 2023
    Posted
    December 2, 2023
    Address
    40 Continental Blvd, Merrimack, NH, 03054-4332

    Description

    Atrium Firm PVC Thoracic Catheter 36FR Straight, part number 15036.

    Reason

    A sterilization nonconformance prematurely aged the product, resulting in an inaccurate labeled expiration date.

    Action

    An Urgent Medical Device - Removal notice was sent via Fed-Ex on October 25, 2023. The letter advises customers to check for and remove from inventory Atrium Firm PVC Catheter 36 FR Straight, part number 15036, lot ME234686. Forward this information to all current and potential Atrium Firm PVC Thoracic Catheter 36FR Straight users within your hospital / facility, or to any customer product was further distributed to. Contact your local Atrium/Getinge Customer Service department at (603) 880-1433 (press option 1), Monday through Friday, between the hours of 8:00 a.m. and 6:00 p.m. (Eastern Time Zone)to request a return authorization (RMA) and shipping instructions to return any affected product.

    Distribution

    US: AL, AZ, CA, FL, IA, IL, IN, MD, MI, MN, NJ, PA, TN & TX

    Quantity

    2460 units (246 cases, 10 units/case)