BEUDAMED
    FDA Enforcement Class II Terminated

    Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128

    Recall: Z-0560-2019 · Reported December 12, 2018

    Enforcement

    Recall Number
    Z-0560-2019
    Event ID
    81524
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Atrium Medical Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 12, 2018
    Initiation Date
    October 12, 2018
    Classification Date
    December 6, 2018
    Termination Date
    May 12, 2020
    Address
    40 Continental Blvd, N/A, Merrimack, NH, 03054-4332, United States

    Description

    Atrium 28Fr PVC Thoracic Catheter RIGHT ANGLE, Part No. 8128

    Reason

    This recall has been initiated in response to a seal defect found in certain sterile barrier pouches containing the device. Affected pouches are un-sealed at the bottom. If the pouch defect is not detected it could represent a serious hazard to the patient. A sterility breach could potentially lead to product contamination. The potentially affected device is used in contact with critical anatomical structures and deep into the body. If contaminated, the consequences for the patient could be severe. The severity of the possible clinical complications depends on the degree of contamination of the device, the microorganisms involved and the patient s risk factors. To date, Getinge/Atrium has not received any reports of patient injury related to this issue.

    Code Info

    ME221275

    Distribution

    Worldwide distribution - US Nationwide distribution, and country of Saudi Arabia.

    Quantity

    2930 units