Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm… recallZ-0339-2007 · Smiths Medical ASD, Inc. · initiated Aug 31, 2006
Terminated All recalls posted in January 2007
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
Mislabeled- The outer diameter (OD) of the shaft is labeled as 11.0 m on the inner, outer and tray label in error. The OD is actually 11.8 mm.
FDA root cause category: Other
What the company is doing
Distributors and hospital consignees were notified via recall letter dated 8/25/06 to return all unused product to the firm. Distributors were asked to notify their customers of the recall.
Recall details
- Recall number
- Z-0339-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Aug 31, 2006
- Posted by the FDA
- Jan 5, 2007
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 197
- Product code
- JOH
- FDA submissions
- K913859
- Distribution
- Worldwide Distribution ---- including USA states of Arkansas, California, Georgia, Illinois, Kansas, Minnesota, Missouri, Ohio, Pennsylvania, Texas and countries of Canada and Netherlands.
Product description
Bivona Adult Tracheostomy Tube, I.D. 8.5 mm, O.D 11.0 mm, Length 88 mm, TTS 11.8 mm, Mfrd by Smiths Medical Critical Care; Product code 670185.
Code information (models, lots, serial numbers)
Lots 1008187, 1023402 and 1012767.
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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