BEUDAMED
    FDA Enforcement Class II Ongoing

    Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

    Recall: Z-0318-2024 · Reported November 22, 2023

    Enforcement

    Recall Number
    Z-0318-2024
    Event ID
    93149
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 22, 2023
    Initiation Date
    September 18, 2023
    Classification Date
    November 16, 2023
    Address
    40 Continental Blvd, N/A, Merrimack, NH, 03054-4332, United States

    Description

    Express Dry Seal Chest Drains (Express): 4000-100N DRAIN, EXPRESS, SINGLE; 4050-100N DRAIN, EXPRESS, BRU

    Reason

    Instructions for Use (IFU) for the Atrium Ocean, Oasis, and Express chest drains do not provide sufficient precaution instruction for proper set up of catheter(s) and patient tube connections with single collection chamber chest drains

    Code Info

    UDI-DI: (1)4000-100N DRAIN, EXPRESS, SINGLE 20650862115134; (2) 4050-100N DRAIN, EXPRESS, BRU 20650862115141 All lots within labeled product expiry Manufacturing Dates: Any product manufactured on and after July 21, 2020 Distribution Dates: Any product shipped on and after August 6, 2020

    Distribution

    Worldwide distribution - US Nationwide and the countries of Algeria, Australia, Austria, Bahrain, Belgium, Brazil, Brunei Darussalam, Canada, Chile, China, Czech Republic Ecuador, Egypt, Finland, France, Germany, Hong Kong, Iceland, Indonesia, Ireland, Israel, Italy, Jordan, Korea, Republic of Kuwait, Latvia, Lithuania, Luxembourg, Malaysia, Malta, Mauritius, Mexico, Montenegro, Netherlands, New Zealand, Norway, Pakistan, Peru, Poland, Portugal, Puerto Rico, Qatar, Russian Federation, Saudi Arabia, Singapore, Slovenia, South Africa, Spain, Sweden, Switzerland, Taiwan Province of China, Thailand Tunisia, Ukraine, United Arab Emirates, United Kingdom, Uruguay.

    Quantity

    48339 cases: 48148 cases US; 193 cases OUS