Smiths Medical Recalls Bivona Tracheostomy Tubes Due to Sterility Labeling Error
Smiths Medical ASD Inc. is recalling 16 Bivona Tracheostomy Tubes because the cartons are labeled 'Sterile' even though the devices are not sold as sterile.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is classified as a Moderate severity recall (Score 2) because it involves a minor labeling error regarding sterility status, which is a documentation issue rather than a direct physical defect or contamination.
Plain-English summary
Smiths Medical ASD Inc. is recalling 16 units of Bivona Tracheostomy Tubes. The recall was initiated because the carton labeling incorrectly indicates that the devices are 'Sterile,' although the devices are not sold as sterile.
The affected units were distributed domestically to California, Florida, Georgia, Idaho, New Jersey, New Mexico, Ohio, and Virginia, as well as internationally to France. Specific part and lot numbers are listed in the official recall documentation.
Consumers and healthcare facilities should check their inventory for the specific part and lot numbers associated with this recall. If the affected units are found, they should be removed from use and returned to the manufacturer or the appropriate regulatory authority as directed.
The recalled product
- Product
- Bivona¿ Tracheostomy Tube Tracheostomy Tubes
- Manufacturer
- Smiths Medical ASD Inc.
- Hazard
- Affected units
- 16
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 (12)
- Part No. (Lot No.): CMZ3241N (DS009716)
- ST16EN80NSC194N (DS009794)
- SU15AN70NSC153N (DS009577)
- FT17IN60NGC114N (DS009894)
- CMZ3331N (DS009761)
- XU17GS50NSF046N (DS009609)
- FT17IN60NGC114N (DS009861)
- AA16ES70NSC110N (DS009586)
- FT17IN70NSC111N (DS009856)
- FT16IN60NGC053N (DS009540)
- FU15AN55NSA076N (DS009464)
- AT17IS60NGC105N (DS009811)
Distribution
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