BEUDAMED
    FDA Enforcement Class II Terminated

    Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation

    Recall: Z-1928-2017 · Reported May 10, 2017

    Enforcement

    Recall Number
    Z-1928-2017
    Event ID
    76965
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Dale Medical Products, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 10, 2017
    Initiation Date
    March 24, 2017
    Classification Date
    May 3, 2017
    Termination Date
    May 21, 2018
    Address
    7 Cross St, Plainville, MA, 02762-1525, United States

    Description

    Dale Medical Stabilock Endotracheal Adhesive Base Product # 273 The Dale Stabilock Endotracheal Tube Bolder 270 is a 2 piece device consisting of an adhesive base, Dale product number 273, that attaches to the patient's skin and a cushioned neckband with tube channel that attaches with hook & loop closures. The 270 is used to secure and stabilize endotracheal tubes, preventing unnecessary movement which can help prevent accidental .extubation

    Reason

    ET Tube Holders contain an adhesive faceplate that may lose its adhesive properties and will not adhere to the patient's face.

    Code Info

    Lot Numbers: 04 07 16 04, 08 16, 05 16 16

    Distribution

    Worldwide Distribution -US ( Nationwide) and Internationally to Canada, Costa Rica, Norway, Paraguay, Ireland, Panama, Ecuador, Hong Kong, Malaysia, Italy, UAE, Guatemala, Iceland, Indonesia, and Saudi Arabia.

    Quantity

    34,770 total