FDA Medical Device Recalls (openFDA)
Smiths Medical ASD Inc.: Bivona Tracheostomy Tube Tracheostomy Tubes
- Recall number
- Z-2114-2018
- Recalling firm
- Smiths Medical ASD Inc.
- Product
- Bivona Tracheostomy Tube Tracheostomy Tubes
- Status
- Terminated
- Initiated
- 2018-04-02
- Posted
- not on file
- Terminated
- 2018-11-14
- Reason
- Carton labeling is printed with "Sterile" indicated labeling, however the device is not sold as sterile.
- Root cause
- Error in labeling
- Action
- Customers were notified via letter on approximately 04/02/2018. Instructions included to determine if there are any affected Customized Bivona Tracheostomy Tubes in inventory, notify customers if the devices have been further distributed, arrange for the return of affected devices, and complete and return the acknowledgement response form.
- Quantity
- 16 units
- Distribution
- Domestic distribution to CA, FL, GA, ID, NJ, NM, OH, VA. International distribution to France.
- Lot, serial or model codes
- Part No. (Lot No.): CMZ3241N (DS009716), ST16EN80NSC194N (DS009794), SU15AN70NSC153N (DS009577), FT17IN60NGC114N (DS009894), CMZ3331N (DS009761), XU17GS50NSF046N (DS009609), FT17IN60NGC114N (DS009861), AA16ES70NSC110N (DS009586), FT17IN70NSC111N (DS009856), FT16IN60NGC053N (DS009540), FU15AN55NSA076N (DS009464), AT17IS60NGC105N (DS009811)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- BTO
- Firm FEI
- 3012307300
- Firm city
- Minneapolis
- Firm state
- MN
- 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