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 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product Number: H84102421, Dale Medical Products, Inc., Plainville, MA 02762
Brand
Dale Medical Products, Inc.
Lot Codes / Batch Numbers
All lots
Products Sold
All lots
Dale Medical Products, Inc. is recalling Dale 242 Blue (Neonate, Infants and Small Children) Tracheostomy Tube Holder, Product Number: H84102 due to Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Revised Labeling : Instructions For use: "Do not trim fastener hook tabs. " Trimming can cause tabs to disengage at the trach plate
Recommended Action
Per FDA guidance
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"
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026