Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D.… recallZ-0046-2007 · Smiths Medical ASD, Inc. · initiated Aug 11, 2006
Terminated All recalls posted in October 2006
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from Smiths Medical ASD, Inc. or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
The length of the shaft is incorrectly stated as 7 mm, instead of the correct 17 mm, on the outer packaging, although the tray label is correct.
FDA root cause category: Other
What the company is doing
Consignees were notified to cease using, and to return the product, by recall letter dated August 2006 and mailed on 8/11/06.
Recall details
- Recall number
- Z-0046-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 11, 2006
- Posted by the FDA
- Oct 19, 2006
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 71 units.
- Product code
- JOH
- FDA submissions
- K913859
- Distribution
- Nationwide.
Product description
Bivona Adult Tracheostomy Tube, Labeled I.D. 6.0 mm, O.D. 8.7 mm, A 7.0 mm, B 0 mm, C 53.0 mm, Mfrd by Smiths Medical Critical Care; REF 60A160.
Code information (models, lots, serial numbers)
Lots 1037018 and 1045416.
Other devices under the same FDA submission
9 devices cleared under K913859 — the recall does not name any of them by identifier. One submission often covers many models, so they may or may not be affected.
- Bivona 850170Icu Medical, Inc. · Tube tracheostomy and tube cuff6 reports
- Bivona 60A160Icu Medical, Inc. · Tube tracheostomy and tube cuff5 reports
- Bivona 60A170Icu Medical, Inc. · Tube tracheostomy and tube cuff5 reports
- Bivona 60A180Icu Medical, Inc. · Tube tracheostomy and tube cuff4 reports
- Bivona 850190Icu Medical, Inc. · Tube tracheostomy and tube cuff4 reports
- Bivona 60A150Icu Medical, Inc. · Tube tracheostomy and tube cuff2 reports
- Bivona 850160Icu Medical, Inc. · Tube tracheostomy and tube cuff1 report
- Bivona 850180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 report
- Bivona 85P045Icu Medical, Inc. · Tube tracheostomy and tube cuff1 report
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 18, 2026. Text above is shown as published by the FDA.
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