Tracheostomy Tubes Recalled for Torn Securement Flange Risk
Smiths Medical recalls PORTEX Bivona tracheostomy tubes due to a manufacturing defect that may cause the securement flange to tear, potentially leading to tube dislodgement.
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 establishes a minimum severity of Severe. The defect affects a critical airway-maintenance device; a torn securement flange could lead to tube dislodgement and loss of proper airway access in dependent patients. No illnesses or deaths are reported in the source text.
Plain-English summary
Smiths Medical ASD Inc. has recalled specific lots of PORTEX Bivona tracheostomy tubes for neonatal, pediatric, and adult patients. A manufacturing defect may cause the securement flange to tear, compromising the tube's ability to remain securely positioned.
If the securement flange tears, the tube could dislodge, preventing proper airway access in patients who depend on tracheostomy for breathing. Tracheostomy tubes are critical devices used to maintain an open airway in patients with compromised breathing ability.
The recalled products have been distributed worldwide. Specific lot numbers are identified for pediatric sizes ranging from 2.5mm to 5.5mm. Healthcare providers and patients should check their tubes against the provided lot number list.
Patients and healthcare providers should immediately identify any affected tubes and contact Smiths Medical ASD Inc. for instructions on obtaining replacement tubes. Use of recalled lots could result in tube dislodgement and loss of proper airway access.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) PEDIATRIC TRACHEOSTOMY TUBE 2.5mm TTS FLEXTEND V NECK, Product Code/List Number/Item Code 67PFS25; b) PEDIATRIC TRACHEOSTOMY TUBE 3.0mm TTS FLEXTEND V NECK , Product Code/List Number/Item Code 67PFS30; c) PEDIATRIC
- 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 10351688518590
- Product Code/List Number/Item Code 67PFS25
- Lot Numbers: 3961256
- 4119091
- 4213406
- 4374410
- 4395754
- b) UDI/DI 10351688518606
- Product Code/List Number/Item Code 67PFS30
- Lot Numbers: 3853403
- 3874324
- 3884244
- 3907973
- 3930052
- 3959311
- 3961752
- 4060198
- 4083906
- 4091413
- 4105249
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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