FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
- Recall number
- Z-0338-06
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
- Status
- Terminated
- Initiated
- 2005-04-19
- Posted
- 2006-01-06
- Terminated
- 2007-12-06
- Reason
- The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.
- Root cause
- Other
- Action
- Consignee was notified via recall letter dated April 19, 2005.
- Quantity
- 11
- Distribution
- California, Indiana and North Carolina.
- Lot, serial or model codes
- Lot G653628.
- 510(k) numbers
- ["K922665"]
- PMA numbers
- not on file
- Product code
- BTO
- 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