FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: 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.
- Recall number
- Z-0046-2007
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- 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.
- Status
- Terminated
- Initiated
- 2006-08-11
- Posted
- 2006-10-19
- Terminated
- 2007-12-04
- Reason
- 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.
- Root cause
- Other
- Action
- Consignees were notified to cease using, and to return the product, by recall letter dated August 2006 and mailed on 8/11/06.
- Quantity
- 71 units.
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lots 1037018 and 1045416.
- 510(k) numbers
- ["K913859"]
- PMA numbers
- not on file
- Product code
- JOH
- Firm FEI
- 1824231
- Firm city
- Gary
- Firm state
- IN
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28