Bivona Tracheostomy Tubes Recalled for Potential Securement Flange Failure
Smiths Medical recalled specific lots of Bivona Tracheostomy Tubes after identifying a manufacturing defect that may cause the securement flange to tear, risking tube displacement.
The agency’s classification
FDA (Devices): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: This is an FDA Class I medical device recall, which per the mandatory rule in the rubric establishes a minimum score of 4. No deaths, serious injuries, or hospitalizations have been reported.
Plain-English summary
Smiths Medical has recalled specific lots of PORTEX Bivona Tracheostomy Silicone Tubes. The recall affects neonatal, pediatric, and adult sizes from 2.5mm to 5.5mm.
A manufacturing defect has been identified in the securement flange of these tubes. The defect may cause the securement flange to tear. The securement flange is the component that attaches and secures the tube to the patient.
The recalled tubes were distributed worldwide. Specific lot numbers for each tube size are identified in the recall notice. Healthcare providers and patients should verify whether their tubes match any of the recalled lot numbers.
Persons using affected tubes should contact their healthcare provider or the manufacturer for guidance.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: 2.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN025; 3.0MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 65SN030; 3.5MM AIRE-CUF NEONATAL TRACHEOSTOMY TUBE…
- Manufacturer
- Smiths Medical ASD Inc.
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 15021312000016
- Product Code/List Number/Item Code 65SN025
- Lot Numbers: 4060220
- 4119090
- 4180463
- 4201335
- 4204802
- 4374400
- 4393388
- b) UDI/DI 15021312000030
- Product Code/List Number/Item Code 65SN030
- Lot Numbers: 3965331
- 4119093
- 4139005
- 4163833
- 4171566
- 4267838
- 4351231
- 4399123
- c) UDI/DI 15021312000061
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 28 recalled by Smiths Medical ASD Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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