Recall archive / FDA device enforcement
PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code... — FDA record Z-2606-2024
Reported ongoing
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date May 29, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N025; b) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N030; c) TTS NEONATAL TRACH TUBE , Product Code/List Number/Item Code 67N035
- 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.
- Classification
- Class I
- Recalling firm
- Smiths Medical ASD Inc.
- Quantity
- Not supplied
- Agency-reported status
- Ongoing
- Source record identifier
- Z-2606-2024
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | a) UDI/DI 15021312006209, Product Code/List Number/Item Code 67N025, Lot Numbers: 3894899, 3949047, 4011355, 4139007, 4153599, 4185400, 4327887, 4331545, 4334876, 4352755, 4353076, 4372094, 4388097, 4400622; b) UDI/DI 15021312006216, Product Code/List Number/Item Code 67N030, Lot Numbers: 3853378, 3868286, 3887733, 3918002, 3939660, 4029491, 4043944, 4051629, 4060201, 4091408, 4113106, 4116109, 4128032, 4148026, 4159991, 4171571, 4185401, 4221331, 4327886, 4331548, 4334878, 4348407, 4374401, 4380992, 4380993, 4389867, 4399126; c) UDI/DI 15021312006223, Product Code/List Number/Item Code 67N035, Lot Numbers: 3868245, 3884266, 3904655, 3923736, 3952406, 3955773, 3961254, 3965335, 4016045, 4016046, 4156603, 4180470, 4216298, 4237347, 4328208, 4334879, 4344968, 4351233, 4362869, 4383593, 4395736 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
Worldwide distribution.
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Report date
- Sep 4, 2024
- Recall initiation date
- May 29, 2024
- Center classification date
- Aug 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.