Z-0572-04

Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013

Name: Z-0572-04 Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013
Creator: Smiths Medical ASD, Inc
Published: 2004-01-26
License: https://open.fda.gov/license/

Abbott Medical / initiated 2004-01-26 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc began a recall of Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013 on 2004-01-26. The reason FDA records is "Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr". 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-0572-04
Status: Terminated
Initiated: 2004-01-26
Posted: 2004-07-20
Terminated: 2012-05-08
Recalling firm: Abbott Medical
Product: Portex Tracheal Tube Guide 15 Fr, non-sterile Catalog Number: 153013
Product code: BSR Stylet, Tracheal Tube
Reason for recall: Tracheal tube guide mislabeled as a 15 Fr instead of a 10 Fr
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Smiths Medical notified consignees by letter dated 1/26/04 by FedEx. Customers are requested to inspect their inventory for the size. Incorrectly labeled product is to be returned for credit or replacement. Customers and dealers are directed to fax back the attached Reply Letter.
Quantity in commerce: 46 cases (230 UNITS)
Distribution: CA, CO, FL, GA, IN, MA, MD, MI. NH, NC, NY, TX, WA
Product codes and lots: Lot Number: K221961

Product code BSR

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)