Z-0260-2007

Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by...

Name: Z-0260-2007 Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by...
Creator: Smiths Medical ASD, Inc.
Published: 2006-11-17
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-11-17 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S on 2006-11-17. The reason FDA records is "Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm". 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-0260-2007
Status: Terminated
Initiated: 2006-11-17
Posted: 2006-12-07
Terminated: 2007-01-12
Recalling firm: Abbott Medical
Product: Custom 5.5 mm Bivona Uncuffed Hyperflex Tracheostomy Tube, I.D. 5.5 mm, O.D. 8.0 mm, length 4.75 mm, Mfrd by Smiths Medical Critical Care; REF HU05JS55NNA112S.
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Mislabeled as to size: The product is 47.5 mm in length, but the label lists the length as 4.75 mm.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The consignee was notified of the problem via recall letter sent on 11/17/06 and given the options of continuing to use the product or of returning it.
Quantity in commerce: 5
Distribution: New York-single hospital consignee
Product codes and lots: Lot CL47189.

Product code JOH

K923878Class IIBivona Customized Tracheostomy TubesBivona Medical Technologies / cleared 1992-12-29

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)