Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube… recallZ-0260-2007 · Smiths Medical ASD, Inc. · initiated Nov 17, 2006
Terminated All recalls posted in December 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
Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
FDA root cause category: Other
What the company is doing
The consignee was notified of the problem via recall letter sent on 11/17/06 and given the options of continuing to use the product or of returning it.
Recall details
- Recall number
- Z-0260-2007
- Recall class
- Not yet classified by the FDA
- Status
- Terminated
- Initiated by the company
- Nov 17, 2006
- Posted by the FDA
- Dec 7, 2006
- Recalling firm
- Smiths Medical ASD, Inc.
- Quantity
- 5
- Product code
- JOH
- FDA submissions
- K923878
- Distribution
- New York-single hospital consignee
Product description
Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.
Code information (models, lots, serial numbers)
Lot CL47189.
Other devices under the same FDA submission
322 devices cleared under K923878 — 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 67PFSS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall166 reports
- Bivona 67PFSS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall115 reports
- Bivona 67PFSS45Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall61 reports
- Bivona 67NFPS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall60 reports
- Bivona 67PFS50Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall35 reports
- Bivona 67PFPS60Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall34 reports
- Bivona 67PFSS50Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall34 reports
- Bivona 67PFS40Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall31 reports
- Bivona 67PFS45Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall23 reports
- Bivona 67NFPS30Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall23 reports
- Bivona 67PFS35Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall19 reports
- Bivona 67PFPS45Icu Medical, Inc. · Tube tracheostomy and tube cuff1 recall15 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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