Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product Number: H84102421, Dale Medical Pr
FDA device recall Z-0447-2008 · posted 2008-01-11 · Terminated
Recall details
- Recalling firm
- Dale Medical Products, Inc.
- Reason for recall
- Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate
- 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"
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- CBH
- Quantity affected
- 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, Jap
- Date initiated
- 2007-09-27
- Date posted
- 2008-01-11
- Date terminated
- 2012-05-09
- Location
- Plainville, MA
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