Recall Z-0446-2008
Dale Medical Products, Inc. · initiated September 27, 2007
Product
Dale 240 Blue (Adults) Tracheostomy Tube Holder, Product Number: H84102401, Dale Medical Products, Inc., Plainville, MA 02762
Codes / lots: All lots
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: Labeling design
Action taken
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"
Details
- Recall number
- Z-0446-2008
- Initiated
- September 27, 2007
- Posted by FDA
- January 11, 2008
- Terminated
- May 9, 2012
- Product code
- CBH – Device, Fixation, Tracheal Tube
- Quantity
- 600,000 units
- 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.
- Recalling firm
- Dale Medical Products, Inc., Plainville, MA
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0447-2008 | Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product…Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to… | 09/27/2007Terminated |