Bivona brand Neonatal TTS Tracheostomy Tubes, sterile… recallZ-0302-06 · Smiths Medical ASD, Inc. · initiated Feb 17, 2005
Terminated All recalls posted in December 2005
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 word PED was printed on the neckflange instead of the word NEO.
FDA root cause category: Other
What the company is doing
Consignees were notified via 'product advisory letter' dated 2/17/05 and requested to either notify all users or to return the product for replacement.
Recall details
- Recall number
- Z-0302-06
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Feb 17, 2005
- Posted by the FDA
- Dec 23, 2005
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 26
- Product code
- BTO
- FDA submissions
- K914088
- Distribution
- Georgia, Illinois, Indiana, Maryland, Tennessee, Texas and Virginia.
Product description
Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
Code information (models, lots, serial numbers)
Lot 1338010.
Other devices under the same FDA submission
19 devices cleared under K914088 — 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 67SP045Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall47 reports
- Bivona 750180Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall2 deaths30 reports
- Bivona 67SP040Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall26 reports
- Bivona 67SP035Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall21 reports
- Bivona 67SN035Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall20 reports
- Bivona 67SP050Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall19 reports
- Bivona 750170Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall19 reports
- Bivona 67SP055Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall16 reports
- Bivona 67SP030Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall15 reports
- Bivona 750160Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall12 reports
- Bivona 67SN025Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall9 reports
- Bivona 67SN030Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall9 reports
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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