Z-0100-2008

Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090

Name: Z-0100-2008 Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
Creator: Smiths Medical ASD, Inc.
Published: 2007-09-18
License: https://open.fda.gov/license/

Abbott Medical / initiated 2007-09-18 / Terminated / root cause: manufacturing process

FDA source

Smiths Medical ASD, Inc. began a recall of Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090 on 2007-09-18. The reason FDA records is "Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0100-2008
Status: Terminated
Initiated: 2007-09-18
Posted: 2007-11-07
Terminated: 2012-05-08
Recalling firm: Abbott Medical
Product: Portex Perfit Percutaneous Tracheostomy Tube Replacement Kit, Sterile Ref: 536090
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Mislabeled. The product is labeled as a size 9.0 mm tracheostomy tube, but the package contains a 7.0 mm tracheostomy tube.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Smiths Medical contacted direct customers and US distributors by letter sent by UPS on Septmeber 18, 2007. US Distributors instructed to return their inventory and provide a customer list to Smiths Medical.
Quantity in commerce: 40 units
Distribution: Nationwide.
Product codes and lots: Lot Number: 1155185

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)