BEUDAMED
    FDA Recall Terminated

    Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N

    Recall: Z-0500-2007 · Initiated November 8, 2006

    Recall

    Recall Number
    Z-0500-2007
    Event Number
    36925
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    CAC
    Status
    Terminated
    Root Cause
    Other
    Initiated
    November 8, 2006
    Posted
    February 15, 2007
    Terminated
    November 27, 2007
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929

    Description

    Atrium Express Dry Seal Chest Drain with Sterile Fluid Path Package Model Number: 4050-170N

    Reason

    Chest drainage tubing incorrectly assembled and may disconnect from patient during use

    Action

    Atrium Medical notiifed accounts by fax to hospitals and phone/email to Distributors on 11/08/06. Product is requested to be returned.

    Distribution

    Nationwide, including CA, and PA.

    Quantity

    49 cases ( 294 units)