Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Incorrect Size Labeling
Smiths Medical ASD Inc. is recalling three Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tubes because the labels display the incorrect size. The units were distributed in Connecticut.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (tracheostomy tube) where the incorrect size labeling could lead to improper use, but the source text does not report any injuries or illnesses.
Plain-English summary
Smiths Medical ASD Inc. is recalling three units of the Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube. These medical devices are intended to provide direct airway access for tracheotomized patients for up to 29 days and may be reprocessed up to 10 times for single-patient use.
The recall was initiated because the product labels contain the incorrect size for the tracheostomy tube. This labeling error could lead to the use of an improperly sized device, which is a risk-of-harm situation for patients requiring airway access.
The affected units are identified by Lot # 3952216. The recall covers three units that were distributed to the state of Connecticut. Healthcare facilities and patients who have these specific units should stop using them and contact Smiths Medical ASD Inc. for further instructions.
The recalled product
- Product
- Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct airway access for a tracheotomized patient for up to 29 days. It may be reprocessed up to 10 times for single patient use.
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 3
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 (1)
- Lot# 3952216
Distribution
Distributed in 1 state:
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