Z-2590-2024 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
- 3138 units
Product Description
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
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
a) UDI/DI 15021312005684, Product Code/List Number/Item Code 60N025, Lot Numbers: 3853476, 3868313, 3911441, 3952404, 3965318, 3991202, 4006287, 4006294, 4097838, 4125826, 4148013, 4185431, 4206833, 4221354, 4238779, 4331627, 4345039, 4348774, 4383653, 4400691