Z-0338-06

Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code...

Name: Z-0338-06 Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code...
Creator: Smiths Medical ASD, Inc.
Published: 2005-04-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-04-19 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70 on 2005-04-19. The reason FDA records is "The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0338-06
Status: Terminated
Initiated: 2005-04-19
Posted: 2006-01-06
Terminated: 2007-12-06
Recalling firm: Abbott Medical
Product: Bivona brand Cuffless Extra Length Fixed Hyperflex Adult Tracheostomy Tube, 110 mm, sterile, Product code 60AFHXL70.
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: The shaft was manufactured approximately 1 to 3 mm under the length specification, and may be 105 mm in length.
Root cause tag: manufacturing process
FDA root cause: Other
Action: Consignee was notified via recall letter dated April 19, 2005.
Quantity in commerce: 11
Distribution: California, Indiana and North Carolina.
Product codes and lots: Lot G653628.

Product code BTO

K922665Class IIBivona Hyperflex Tracheostomy TubeBivona Medical Technologies / cleared 1993-01-07

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)