Z-0302-06

Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040

Name: Z-0302-06 Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040
Creator: Smiths Medical ASD, Inc.
Published: 2005-02-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-02-17 / Terminated

FDA source

Smiths Medical ASD, Inc. began a recall of Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040 on 2005-02-17. The reason FDA records is "The word PED was printed on the neckflange instead of the word NEO". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0302-06
Status: Terminated
Initiated: 2005-02-17
Posted: 2005-12-23
Terminated: 2007-12-04
Recalling firm: Abbott Medical
Product: Bivona brand Neonatal TTS Tracheostomy Tubes, sterile, product code 67N040.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: The word PED was printed on the neckflange instead of the word NEO.
FDA root cause: Other
Action: Consignees were notified via 'product advisory letter' dated 2/17/05 and requested to either notify all users or to return the product for replacement.
Quantity in commerce: 26
Distribution: Georgia, Illinois, Indiana, Maryland, Tennessee, Texas and Virginia.
Product codes and lots: Lot 1338010.

Product code BTO

K914088Class IIBivona Aire-Cuf(r) Pediatric Tracheostomy TubeBivona Medical Technologies / cleared 1991-10-23

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)