BEUDAMED
    FDA Recall Terminated

    PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.

    Recall: Z-1987-2013 · Initiated July 16, 2013

    Recall

    Recall Number
    Z-1987-2013
    Event Number
    65678
    Firm
    Atrium Medical Corporation
    FEI Number
    3011175548
    Product Code
    KDQ
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    July 16, 2013
    Posted
    August 20, 2013
    Terminated
    July 15, 2014
    Address
    5 Wentworth Dr, Hudson, NH, 03051-4929

    Description

    PleuraGuide Disposable Chest Tube Kit; Product codes: 17100, 17150, and 17200. Indicated to assist with the insertion of thoracic catheters.

    Reason

    Individual component's IFUs are not included with the kit.

    Action

    Notice of correction was sent on July 18, 2013 via UPS and e-mail to the field representatives that represent these accounts. The notification identifies the problem, product, and risk factors. It provides instructions how to handle the product that may be affected. Additional labeling will be added to the kit to include instructions for use for the additional components. Atrium Medical will confirm through tracking of the UPS letters that each consignee has received the letter of correction. This shall be 100%. Where a UPS delivery cannot be confirmed, Atrium Medical will make good faith effort to contact the consignee to ensure that the letter was received.

    Distribution

    Nationwide Distribution.

    Quantity

    6,516 units