FDA Enforcement
Class I
Ongoing
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
Recall: Z-2590-2024
·
Reported September 4, 2024
Enforcement
- Recall Number
- Z-2590-2024
- Event ID
- 94852
- Classification
- Class I
- Status
- Ongoing
- Product Type
- Devices
- Firm
- Smiths Medical ASD Inc.
- Voluntary / Mandated
- Voluntary: Firm initiated
- Initial Notification
- Letter
- Report Date
- September 4, 2024
- Initiation Date
- May 29, 2024
- Classification Date
- August 23, 2024
- Address
- 6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States
Description
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
Reason
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.
Code Info
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
Distribution
Worldwide distribution.
Quantity
3138 units