Events

Recall of Dale 242 Blue

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
    45460
  • Event Risk Class
    Class 2
  • Event Number
    Z-0447-2008
  • Event Date Posted
    2008-01-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-05-09
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=65505
  • 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
    Trachestomy Tube Holder - Product Code CBH
  • Reason
    Revised labeling : instructions for use: "do not trim fastener hook tabs. " trimming can cause tabs to disengage at the trach plate.
  • Action
    Dale Medical notified Distributors by letter dated 9/27/07, identified as an Urgent Medical Device Correction Letter. The letter requested distributors to notify all their customers by letter. The Correction Letter reminded users to take notice of new labeling " Do not trim fasterner hook tabs"

Device

Dale 242 Blue
  • Model / Serial
    All lots
  • Product Classification
    Anesthesiology Devices
  • Device Class
    1
  • Implanted device?
    No
  • Distribution
    Worldwide-USA and countries of Canada, Austria, Belgium, Denmark, Finland, France, Germany, Greece, Iceland, Italy, The Netherlands, Norway, The UK, Spain, Switzerland, Australia, Hong Kong,India, Japan, Korea, Malaysia, New Zealand, The Philippines,Singapore, Taiwan, ROC, Brazil, Bermuda, Chile, Costa Rica,Ecuador, Mexico, Panama, Venezuela, Thailand, Saudi Arabia, and The United Arab Emirates.
  • Product Description
    Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product Number: H84102421, Dale Medical Products, Inc., Plainville, MA 02762
  • Manufacturer
    Dale Medical Products, Inc.

Manufacturer

Dale Medical Products, Inc.
  • Manufacturer Address
    Dale Medical Products, Inc., 7 Cross St, P.O. Box 1556, Plainville MA 02762-0556
  • Manufacturer Parent Company (2017)
    Dale Medical Products Inc.
  • Source
    USFDA