FDA Enforcement
Class I
Ongoing
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
Recall: Z-2593-2024
·
Reported September 4, 2024
Enforcement
- Recall Number
- Z-2593-2024
- 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: 2.5MM UNCUFFED NEONATAL FLEXTEND PLUS TRACHEOSTOMY TUBE W/NEO STRAIGHT STRAP, Product Code/List Number/Item Code 60NFPS25
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
UDI/DI 15021312516678, Product Code/List Number/Item Code 60NFPS25, Lot Numbers: 3853440, 3874312, 3891526, 3904670, 3923733, 3946227, 3952384, 3965919, 3991145, 4015537, 4035730, 4095917, 4119108, 4134019, 4156630, 4173731, 4179354, 4327881, 4334986, 4351236, 4374430, 4388157, 4395780,
Distribution
Worldwide distribution.