Z-0301-06

Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70

Name: Z-0301-06 Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70
Creator: Smiths Medical ASD, Inc.
Published: 2005-07-25
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-07-25 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70 on 2005-07-25. The reason FDA records is "Instructions for use included in the package are for a different tracheostomy tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0301-06
Status: Terminated
Initiated: 2005-07-25
Posted: 2005-12-23
Terminated: 2007-12-04
Recalling firm: Abbott Medical
Product: Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: Instructions for use included in the package are for a different tracheostomy tube.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified via 'precautionary product advisory notification' letter dated July 25, 2005.
Quantity in commerce: 91
Distribution: Nationwide.
Product codes and lots: Lot G667991.

Product code BTO

K894614Class IIBivona Aire-Cuf Adjustable Tracheostomy TubeBivona Medical Technologies / cleared 1989-10-13

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)