Bivona Tracheostomy Tubes Recalled Due to Securement Flange Tear Risk
Smiths Medical is recalling specific lots of PORTEX Bivona Tracheostomy Tubes because a manufacturing defect may cause the securement flange to tear.
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 requires a minimum severity of 4; however, no deaths, hospitalizations, or injuries have been reported in the source, so the score remains 4 rather than 5.
Plain-English summary
Smiths Medical ASD Inc. is recalling specific lots of PORTEX Bivona Tracheostomy Silicone Tubes. The recalled products include three sizes of AIRE-CUF TRACHY TUBE: 6.0MM Mid-Range, 7.0MM Mid-Range, and 8.0MM Mid-Range. Approximately 25,283 units have been distributed worldwide.
The reason for the recall is a manufacturing defect identified in the securement flange. The flange may tear in affected units.
The recalled product
- Product
- PORTEX Bivona Tracheostomy Silicone Tube, labeled as: a) AIRE-CUF TRACHY TUBE 6.0MM MID-RANGE , Product Code/List Number/Item Code 750160; b) AIRE-CUF TRACHY TUBE 7.0MM MID-RANGE , Product Code/List Number/Item Code 750170; c) AIRE-CUF TRACHY TUBE 8.0MM MID-RANGE , Produc
- Manufacturer
- Smiths Medical ASD Inc.
- Category
- Medical Device — Tracheostomy
- Hazard
- flange-tear
- manufacturing-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 15021312006407
- Product Code/List Number/Item Code 750160
- lot Numbers: 3790021
- 3797124
- 3797136
- 3797137
- 3800590
- 3801380
- 3801381
- 3827984
- 3827985
- 3827986
- 3839579
- 3845047
- 3889987
- 3889988
- 3889989
- 3889990
- 3889991
- 3889992
Distribution
Distribution scope not specified by the agency.
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