Z-0714-06

Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080

Name: Z-0714-06 Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080
Creator: Smiths Medical ASD, Inc.
Published: 2006-03-07
License: https://open.fda.gov/license/

Abbott Medical / initiated 2006-03-07 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080 on 2006-03-07. The reason FDA records is "Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm". 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-0714-06
Status: Terminated
Initiated: 2006-03-07
Posted: 2006-04-06
Terminated: 2012-05-08
Recalling firm: Abbott Medical
Product: Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Smiths Medical ASD, Inc. notified US customers by letter dated 3/7/06. Accounts are requested to return inventory.
Quantity in commerce: 5350 units (107 cases)
Distribution: Nationwide
Product codes and lots: Lot 490694

Product code BTO

K030381Class IIPortex Blue Line Ultra Tracheostomy Tube (Cuffed) with Reusable Inner CannulaPortex , Ltd. / cleared 2003-08-27

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)