FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.
- Recall number
- Z-0378-2007
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Bivona Laryngectomy Tube, Cuffless, Silicone, I.D. 9.5 mm, O.D 20.0 mm, Length 85 mm, Mfrd by Smiths Medical Critical Care; REF BOSL1L.
- Status
- Terminated
- Initiated
- 2006-12-15
- Posted
- 2007-01-25
- Terminated
- 2007-12-04
- Reason
- The label incorrectly states the outer diameter of the tube is 20.0 mm when it is actually 12.0 mm.
- Root cause
- Other
- Action
- Consignees were notified via recall letter dated 12/15/06. Distributors were requested to provide the firm with final user name and address information so that they could notify them of the recall. The firm is advising users that they can either return the product for replacement or continue to use it now that they are aware of the labeling error.
- Quantity
- 117
- Distribution
- Worldwide, including USA, Canada, Netherlands and United Kingdom.
- Lot, serial or model codes
- Lots 1055779, 1245930, 1263830, 1302670, 1310500, 1324570, 1351420, 1351480, G654810, G689730 and G726388.
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- KAC
- 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