Z-0869-05

Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 535090

Name: Z-0869-05 Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 535090
Creator: Smiths Medical ASD, Inc.
Published: 2005-05-16
License: https://open.fda.gov/license/

Abbott Medical / initiated 2005-05-16 / Terminated

FDA source

Smiths Medical ASD, Inc. began a recall of Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 535090 on 2005-05-16. The reason FDA records is "Guiding catheter may have thinner and weaker sidewalls than designed, and may break". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0869-05
Status: Terminated
Initiated: 2005-05-16
Posted: 2005-06-04
Terminated: 2012-05-08
Recalling firm: Abbott Medical
Product: Portex Per-Fit Percutaneous Dilational Tracheostomy Kit , ID 9.0mm Product Number: 535090
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Guiding catheter may have thinner and weaker sidewalls than designed, and may break.
FDA root cause: Other
Action: Smith Medical ASD initiated recall by letter on/about about May 16, 2005.
Distribution: Natiowide Foreign: Canada, Mexico and East Timor.
Product codes and lots: Lot Numbers: K515076, K518078, K558496, K586109, K614402, K629274

Product code JOH

K031057Class IIPer-Fit Percutaneous Dilational Tracheostomy KitPortex, Inc. / cleared 2003-07-18

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)