Z-2607-2024 Class I Ongoing
Recall Details
- Product Type
- Devices
- Report Date
- September 4, 2024
- Initiation Date
- May 29, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
Product Description
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: TTS NEONATAL TRACHY TUBE 4.0MMTIGHT TO SHAFT CUFF , Product Code/List Number/Item Code 67N040
Reason for Recall
Smiths Medical has identified that the securement flange of specific lots of the Bivona Neonatal/Pediatric and Adult Tracheostomy products may tear because of a manufacturing defect.
Distribution Pattern
Worldwide distribution.
Code Information
UDI/DI 15021312006230, Product Code/List Number/Item Code 67N040, Serial Numbers: 3877658, 3901313, 3923737, 3936563, 3942521, 3965334, 4016051, 4331550, 4334880, 4352757, 4362870, 4369535, 4380068