Tracheostomy Tubes Recalled for Manufacturing Defect Affecting Securement Flange
Smiths Medical recalled specific lots of PORTEX Bivona Tracheostomy Tubes due to a manufacturing defect that may cause the securement flange to tear. Affected products were distributed worldwide.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: FDA Class I classification mandates a minimum severity of 4 per the recall rubric. The manufacturing defect affects a critical airway device where structural failure could compromise patient safety.
Plain-English summary
Smiths Medical recalled specific lots of the PORTEX Bivona Tracheostomy Tubes, medical devices used to maintain open airways in patients requiring breathing assistance. Four product codes are affected: 65N025, 65N030, 65N035, and 65N040, with specific lot numbers identified in the FDA recall notice.
The recall was prompted by identification of a manufacturing defect in which the securement flange—the part that holds the tube in place—may tear. A flange failure could compromise the tube's ability to remain properly secured.
These tubes were distributed worldwide. Patients, caregivers, and healthcare facilities should verify whether they have any of the affected lots by checking the product code and lot number against the FDA recall information. Healthcare providers should be contacted if a patient is currently using an affected device.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N025; b) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65N030; c) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- manufacturing-defect
- structural-defect
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- a) UDI/DI 15021312005905
- Product Code/List Number/Item Code 65N025
- Lot Numbers: 3949029
- 4138994
- 4171564
- 4334857
- 4383590
- b) UDI/DI 15021312005912
- Product Code/List Number/Item Code 65N030
- Lot Numbers: 3917999
- 3965333
- 4142429
- 4161978
- 4185397
- 4197598
- 4334858
- 4348373
- c) UDI/DI 15021312005929
- Product Code/List Number/Item Code 65N035
- Lot Numbers: 3871033
Distribution
Distribution scope not specified by the agency.
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