FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
- Recall number
- Z-0301-06
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
- Status
- Terminated
- Initiated
- 2005-07-25
- Posted
- 2005-12-23
- Terminated
- 2007-12-04
- Reason
- Instructions for use included in the package are for a different tracheostomy tube.
- Root cause
- Other
- Action
- Consignees were notified via 'precautionary product advisory notification' letter dated July 25, 2005.
- Quantity
- 91
- Distribution
- Nationwide.
- Lot, serial or model codes
- Lot G667991.
- 510(k) numbers
- ["K894614"]
- 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