Z-0395-06

Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm...

Name: Z-0395-06 Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm...
Creator: Smiths Medical ASD, Inc.
Published: 2005-12-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-12-16 / Terminated / root cause: packaging

FDA source

Smiths Medical ASD, Inc. began a recall of Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80 on 2005-12-16. The reason FDA records is "Sterility is compromised by incomplete package seal". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0395-06
Status: Terminated
Initiated: 2005-12-16
Posted: 2006-01-18
Terminated: 2007-02-08
Recalling firm: Abbott Medical
Product: Bivona brand Mid-Range Aire-Cuf Extra Length Fixed Hyperflex Adult Tracheostomy Tube, I.D. 8.0 mm O.D. 11.0mm length 120 mm; REF 75FHXL80.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Sterility is compromised by incomplete package seal.
Root cause tag: packaging
FDA root cause: Other
Action: Certified letters were sent to each consignee on 12/ 16/05 and distributors were requested to notify their customers of the recall.
Distribution: Nationwide and Canada.
Product codes and lots: Lots G711870 and G711871.

Product code JOH

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)