Z-2600-2024 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: 2.5MM PEDIATRIC UNCUFFED FLEXTEND PLUS TRACHEOSTOMY TUBE WITH NEONATE STRAIGHT NECKSTRAP, Product Code/List Number/Item Code 60PFSS25
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 15021312516753. Product Code/List Number/Item Code 60PFSS25, Lot Numbers: 3868303, 3894869, 3949045, 3991182, 3997819, 4038948, 4075236, 4086044, 4148027, 4163850, 4185425, 4223732, 4234640, 4327882, 4352790, 4362855, 4389906