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U.S. Department of Health and Human Services

Class 2 Device Recall Dale 242 Blue

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  Class 2 Device Recall Dale 242 Blue see related information
Date Initiated by Firm September 27, 2007
Date Posted January 11, 2008
Recall Status1 Terminated 3 on May 09, 2012
Recall Number Z-0447-2008
Recall Event ID 45460
Product Classification Trachestomy Tube Holder - Product Code CBH
Product Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product Number: H84102421, Dale Medical Products, Inc., Plainville, MA 02762
Code Information All lots
Recalling Firm/
Manufacturer		 Dale Medical Products, Inc.
7 Cross St
P.O. Box 1556
Plainville MA 02762-0556
For Additional Information Contact SAME
508-695-9316
Manufacturer Reason
for Recall		 Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate
FDA Determined
Cause 2		 Labeling design
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"
Quantity in Commerce 65,000
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.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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