FDA Medical Device Recalls (openFDA)
Smiths Medical ASD, Inc.: Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
- Recall number
- Z-0930-05
- Recalling firm
- Smiths Medical ASD, Inc.
- Product
- Bivona brand Pediatric TTS Tracheostomy Tube, 3.5 mm tracheostomy tubes with a 3.5mm obturator ; product code 67P035.
- Status
- Terminated
- Initiated
- 2005-04-26
- Posted
- 2005-06-25
- Terminated
- 2005-10-26
- Reason
- The obturator may be 3.0 mm in length instead of the labeled 3.5 mm.
- Root cause
- Other
- Action
- Consignees were notified via letter dated 4/26/05.
- Quantity
- 48
- Distribution
- Connecticut, Georgia, Illinois, Indiana, Minnesota, Missouri, New Mexico, and North Carolina.
- Lot, serial or model codes
- Lot G651610.
- 510(k) numbers
- ["K914088"]
- 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