Recall Z-0447-2008 ยท CBH Device, Fixation, Tracheal Tube
Dale Medical Products, Inc.
Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product Number: H84102421, Dale Medical Products, Inc., Plainville, MA 02762
| Date | Jan 11, 2008 (initiated Sep 27, 2007) |
| Status | Terminated |
| Reason | Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate |
| Root cause | 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 | 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, Co |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.