FDA issues Class I recall on tracheostomy tubes after 12 injuries
The U.S. Food and Drug Administration (FDA) has issued a recall on behalf of Smiths Medical for a line of its tracheostomy tubes after 12 patients were reported injured. Due to the risk of death, the recall has been given a Class I designation, reserved for the most serious types. The products are not to be used and are to be immediately removed from inventory.
Smiths Medical’s BLUSelect, BLUgriggs, and BLUperc devices are used to help create an artificial airway during a medical emergency and serve as an easier-to-place tracheostomy tube to help a patient breathe.
However, the devices have a manufacturing defect that may cause the pilot balloon—which inflates the tracheostomy cuff to open the windpipe—to disconnect. If it does, pressure may not be maintained, which can lead to inadequate ventilation, increased risk of aspiration and potentially kill a patient.
Despite the injuries, there have been no reported deaths associated with the BLU tubes.
What is being recalled?
The tarsectomy tubes are often sold in kits. Below is a complete list of products subject to the recall.
- BLUselect Tracheostomy Tube Kits
- BLUselect Suctionaid Tracheostomy Tube Kits
- BLUgriggs Percutaneous Dilation Tracheostomy Procedural Kit—or Tray with BLUselect Tracheostomy Tube, with or without Forceps
- BLUperc Dilation Procedural Tray with Single Stage Dilator Products
- BLUperc Percutaneous Dilation Tracheostomy Procedural Kit or Tray, with or without BLUselect Tracheostomy Tube
Details on the full lot and associated serial numbers can be found here.
Next steps
Use of defective products should cease immediately, and they are to be discarded. If they cannot be disposed of, any recalled BLU kit or tube should be quarantined.
Smiths Medical notified all known customers on June 13 about the manufacturing defect. In the letter, they requested a customer response form be filled out and emailed to smithsmedical8551@sedgwick.com for a refund or replacement.
The company and FDA are also asking providers to share the full recall notice, which can be found here.
Chad is an award-winning writer and editor with over 15 years of experience working in media. He has a decade-long professional background in healthcare, working as a writer and in public relations.