BEUDAMED
    FDA Recall Terminated

    Dale 240 Blue (Adults) Tracheostomy Tube Holder, Product Number: H84102401, Dale Medical Products, Inc., Plainville, MA 02762

    Recall: Z-0446-2008 · Initiated September 27, 2007

    Recall

    Recall Number
    Z-0446-2008
    Event Number
    45460
    Firm
    Dale Medical Products, Inc.
    FEI Number
    1214422
    Product Code
    CBH
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    September 27, 2007
    Posted
    January 11, 2008
    Terminated
    May 9, 2012
    Address
    7 Cross St P.O. Box 1556, Plainville, MA, 02762-0556

    Description

    Dale 240 Blue (Adults) Tracheostomy Tube Holder, Product Number: H84102401, Dale Medical Products, Inc., Plainville, MA 02762

    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"

    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.

    Quantity

    600,000 units