Tracheostomy Tubes Recalled Due to Securement Flange Tears
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because the securement flange may tear due to a manufacturing defect. These tubes are used for neonatal, pediatric, and adult patients 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: FDA Class I medical device recall with no reported adverse events. The defect affects the securement mechanism of a tracheostomy tube, a device critical for airway management.
Plain-English summary
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes for neonatal, pediatric, and adult patients due to a manufacturing defect. The securement flange, which holds the tube in place, may tear.
Affected product codes are 60PFS25, 60PFS30, 60PFS35, 60PFS40, 60PFS45, 60PFS50, and 60PFS55. The tubes have been distributed worldwide across multiple lot numbers for each size.
Patients and healthcare providers should verify the lot number of their tracheostomy tubes against the recall list provided by Smiths Medical.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PAED. TRACHEOSTOMY TUBE 2.5MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS25; b) PAED. TRACHEOSTOMY TUBE 3.0MM STANDARD FLEXTEND PLUS , Product Code/List Number/Item Code 60PFS30; c) PAED.…
- 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 15021312005837
- Product Code/List Number/Item Code 60PFS25
- Lot Numbers: 3868288
- 3901288
- 3917984
- 3942491
- 3952376
- 3988093
- 4015545
- 4075235
- 4086043
- 4196278
- 4216321
- 4335004
- 4348474
- b) UDI/DI15021312005844
- Product Code/List Number/Item Code 60PFS30
- Lot Numbers: 3853454
- 3868300
- 3871052
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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