Events

Recall of Device Recall Device, fixation, tracheal tube

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Dale Medical Products, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    76965
  • Event Risk Class
    Class 2
  • Event Number
    Z-1928-2017
  • Event Initiated Date
    2017-03-24
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2018-05-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=154789
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Device, fixation, tracheal tube - Product Code CBH
  • 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

Device

Device Recall Device, fixation, tracheal tube
  • Model / Serial
    Lot Numbers: 04 07 16 04, 08 16, 05 16 16
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • 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.
  • Product 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
  • Manufacturer
    Dale Medical Products, Inc.

Manufacturer

Dale Medical Products, Inc.
  • Manufacturer Address
    Dale Medical Products, Inc., 7 Cross St, Plainville MA 02762-1525
  • Manufacturer Parent Company (2017)
    Dale Medical Products Inc.
  • Source
    USFDA