FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080
- Recall number
- Z-0714-06
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080
- Status
- Terminated
- Initiated
- 2006-03-07
- Posted
- 2006-04-06
- Terminated
- 2012-05-08
- Reason
- Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm
- Root cause
- Other
- Action
- Smiths Medical ASD, Inc. notified US customers by letter dated 3/7/06. Accounts are requested to return inventory.
- Quantity
- 5350 units (107 cases)
- Distribution
- Nationwide
- Lot, serial or model codes
- Lot 490694
- 510(k) numbers
- ["K030381"]
- PMA numbers
- not on file
- Product code
- BTO
- Firm FEI
- 1217052
- Firm city
- Keene
- Firm state
- NH
- 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