CLASS II Device recall · Reported 16 Sep 2020 · FDA Enforcement Report
Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube recalled
Smiths Medical ASD is recalling Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct, distributed in Connecticut. The recall was initiated on 28 Aug 2020 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-2946-2020
- FDA event ID
- 86345
- Recalling firm
- Smiths Medical ASD, Minneapolis, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 28 Aug 2020
- FDA classified
- 9 Sep 2020
- Reported
- 16 Sep 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 28 Aug 2020 | Recall initiated by company | |
| 9 Sep 2020 | Classified by FDA | +12 days |
| 16 Sep 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Label has the incorrect size for the tracheotomy tube.
Product as listed by the FDA
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.
Where it was distributed
US Distribution to state of: CT
Questions about this recall
Is Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct recalled?
Yes. Smiths Medical ASD recalled Bivona Mid-Range Aire-Cuf Adult Tracheostomy Tube This tube is intended to provide direct on 28 Aug 2020. The recall is Class II and its status is Terminated. Recall number Z-2946-2020.
Why was it recalled?
Label has the incorrect size for the tracheotomy tube.
Which lots are affected?
Lot# 3952216
Where was it sold?
US Distribution to state of: CT
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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