BEUDAMED
    FDA Recall 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 · Initiated March 24, 2017

    Recall

    Recall Number
    Z-1928-2017
    Event Number
    76965
    Firm
    Dale Medical Products, Inc.
    FEI Number
    1214422
    Product Code
    CBH
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 24, 2017
    Terminated
    May 21, 2018
    Address
    7 Cross St, Plainville, MA, 02762-1525

    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.

    Action

    Dale Medical notified accounts (OUS) on March 24, 2017 and US accounts on April 7, 2017 advising them to review inventory, if you have any of the noted Lot numbers in stock contact your customers that may have received the identified lot numbers of 270 ET Tube holders and remove suspected product.. Dale Medical will replace product. For questions customers were instructed to call 508-695-9316 ext. 143

    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