Z-0927-03

Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40

Name: Z-0927-03 Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40
Creator: Portex, Inc
Published: 2003-02-20
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-02-20 / Terminated

FDA source

Portex, Inc began a recall of Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40 on 2003-02-20. The reason FDA records is "May have incorrectly printed graduation markings along the tube shaft". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0927-03
Status: Terminated
Initiated: 2003-02-20
Posted: 2003-06-12
Terminated: 2003-12-10
Recalling firm: Abbott Medical
Product: Bivona brand Adjustable Hyperflex Tracheostomy Tube, Pediatric, cuffless; catalog # 60HA40.
Product code: KOH Instrument, Manual, General Obstetric-Gynecologic
Reason for recall: May have incorrectly printed graduation markings along the tube shaft.
FDA root cause: Other
Action: A recall letter dated February 20, 2003 was issued to each customer. Customers were instructed to cease use of the lot and to return the product to Portex.
Quantity in commerce: 49
Distribution: Nationwide, England and France
Product codes and lots: Lot 1134710

Product code KOH

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)