Z-1017-04

Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080

Name: Z-1017-04 Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080
Creator: Smiths Medical ASD, Inc
Published: 2004-05-19
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-05-19 / Terminated

FDA source

Smiths Medical ASD, Inc began a recall of Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080 on 2004-05-19. The reason FDA records is "Incompatible products may cause potential trachea trauma". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1017-04
Status: Terminated
Initiated: 2004-05-19
Posted: 2004-07-20
Terminated: 2006-05-02
Recalling firm: Abbott Medical
Product: Portex Inner Cannula for Tracheostomy Tube, 8.0 mm, REF Code 566080
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Incompatible products may cause potential trachea trauma
FDA root cause: Other
Action: Smiths Medical ASD notified the consignees by letter, dated 5/21/04. All responses to the notification are to be completed by fax and directed to Smiths Medical Regulatory Affairs Departement. The recalled products are to be returned and scrapped by Smiths Medical.
Quantity in commerce: 60,400
Distribution: Nationwide
Product codes and lots: All Lot Numbers

Product code JOH

K902180Class ITracheal Tube StyletSims Surgical, Inc. / cleared 1990-07-19

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)