Z-1039-03

Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090

Name: Z-1039-03 Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
Creator: Portex Inc.
Published: 2003-06-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-06-18 / Terminated / root cause: labeling and UDI

FDA source

Portex Inc. began a recall of Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090 on 2003-06-18. The reason FDA records is "Mislabeled:Tracheostomy tube was not fenestrated as specified on the label". 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-1039-03
Status: Terminated
Initiated: 2003-06-18
Posted: 2003-07-23
Terminated: 2004-03-31
Recalling firm: Abbott Medical
Product: Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090
Product code: BTO Tube, Tracheostomy (W/Wo Connector)
Reason for recall: Mislabeled:Tracheostomy tube was not fenestrated as specified on the label
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Portex notified four user facilities by telephone on June 18th and 19th, 2003 . The consignees were instructed to check their inventory for any affected product and to call to make arrangements for the return and credit of the affected product. If the product was in use, they were instructed to remove the fenestrated label on the inflation line and to inform the patient and healthcare provider of the discrepancy.
Quantity in commerce: 11 units
Distribution: CA, GA, KA, MO
Product codes and lots: Lot Number: 905486 EXP: 2004-05

Product code BTO

K922749Class IILow Profile Tracheostomy TubeConcord/Portex / cleared 1992-09-02

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)