Recall Alert: Smiths Medical Withdraws Specific Bivona Tracheostomy Tubes
This recall pertains to the removal of certain medical devices from their areas of use or sale. The FDA has classified this recall as the most serious category. Continued use of this device may result in significant injury or fatality.
Products Involved
Image of defective torn flange.
Product Names:
- Bivona Aire-Cuf, TTS, Uncuffed, Mid-Range Neonatal/Pediatric Tracheostomy Tubes
- Bivona Aire-Cuf, TTS, Cuffless FlexTend, TTS FlexTend Adult Tracheostomy Tubes
Recommended Actions
Do not use any Bivona tracheostomy tubes from the specified lot numbers. Dispose of them appropriately.
On May 29, 2024, Smiths Medical dispatched an Urgent Medical Device Notification to all impacted customers suggesting the following:
- Be mindful of the instructions, warnings, and cautions included in the Instructions for Use.
- Inspect all inventory for affected products.
- Refrain from using any affected products.
- Dispose of all affected products in accordance with your institution’s standard procedures.
- Disseminate this notification to all potential device users, including any alternate locations where the devices might be utilized.
- Fill out and return the Customer Response Form to smithsmedical3513@sedgwick.com within 10 days of receipt.
- Reach out to your local Smiths Medical representative for assistance regarding replacement products and/or credits.
- Distributors must promptly inform any customers who may have received the affected products to ensure they complete and return the response form via email.
Cause for Recall
Smiths Medical is recalling certain lots of Bivona Neonatal/Pediatric and Adult Tracheostomy tubes due to a manufacturing defect that could lead to the securement flange tearing.
Utilization of these affected products could result in severe health risks, including inadequate ventilation, compromised airway protection, and even death.
There have been 35 documented injuries, alongside two confirmed fatalities.
Intended Use
Bivona neonatal/pediatric and adult tracheostomy tubes serve to offer direct airway access for patients with a tracheostomy for periods of up to 29 days. Certain tubes can be reprocessed and reused multiple times by the same patient.
Contact Information
For inquiries regarding this recall, U.S. customers should reach Global Complaint Management at 1-866-216-8806 or via email at globalcomplaints@icumed.com. Customers may also contact Customer Service at customerservice@icumed.com or 1-800-258-5361.
Further FDA Resources
- Entries from the Medical Device Recall Database:
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK; Product Code/List Number/Item Code 67PFS25
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) 2.5mm TTS CUFFED NEONATAL TRACHEOSTOMY TUBE; Product Code/List Number/Item Code 67SN025
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 4.0mm TTS FLEXTEND PLUS V FLANGE; Product Code/List Number/Item Code 67PFP40
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND STRAIGHT FLANGE; Product Code/List Number/Item Code 67NFPS25
Unique Device Identifier (UDI)
The unique device identifier (UDI) aids in tracing each medical device from production to patient use in the U.S. It facilitates more precise reporting and analysis of adverse events, allowing for swift identification and resolution of potential issues.
Reporting Problems
Healthcare professionals and consumers can report any adverse reactions or quality issues experienced with these devices to MedWatch: The FDA Safety Information and Adverse Event Reporting Program.