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Terminated

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

FDA Recall Z-0446-2008 · Posted 2008-01-11

Recalling FirmDale Medical Products, Inc.
Recall StatusTerminated
Product CodeCBH
Date Initiated2007-09-27
Date Terminated2012-05-09
Product Quantity600,000 units

Reason for Recall

Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate

Firm 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"

Root Cause

Labeling design

Distribution Pattern

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.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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