PORTEX Bivona Tracheostomy Tube Securement Flange May Tear
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. The recall affects neonatal, pediatric, and adult versions distributed worldwide.
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 recall. Per the severity rubric, FDA Class I recalls must score at least 4 (Severe). No deaths or serious injuries have been reported, so the score remains 4 rather than escalating to 5 (Critical).
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of the PORTEX Bivona Tracheostomy Silicone Tube due to a manufacturing defect that may cause the securement flange to tear.
The recall affects Neonatal, Pediatric, and Adult versions of the PORTEX Bivona Tracheostomy Tube (Product Code 60N025, UDI/DI 15021312005684). Approximately 3138 units have been distributed worldwide. The affected lot numbers are: 3853476, 3868313, 3911441, 3952404, 3965318, 3991202, 4006287, 4006294, 4097838, 4125826, 4148013, 4185431, 4206833, 4221354, 4238779, 4331627, 4345039, 4348774, 4383653, and 4400691.
The securement flange keeps the tracheostomy tube in the correct position. If the flange tears, the tube cannot be properly secured, which is a critical concern for patients who depend on tracheostomy tubes for breathing.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) NEONATAL TRACHEOSTOMY TUBE , Product Code/List Number/Item Code 60N025
- Manufacturer
- Smiths Medical ASD Inc.
- Affected units
- 3,138
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 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
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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