Z-0569-04

PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080

Name: Z-0569-04 PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080
Creator: Smiths Medical ASD, Inc.
Published: 2003-12-12
License: https://open.fda.gov/license/

Abbott Medical / initiated 2003-12-12 / Terminated / root cause: labeling and UDI

FDA source

Smiths Medical ASD, Inc. began a recall of PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080 on 2003-12-12. The reason FDA records is "Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm". 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-0569-04
Status: Terminated
Initiated: 2003-12-12
Posted: 2004-07-20
Terminated: 2006-05-02
Recalling firm: Abbott Medical
Product: PER-FIT Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube REF # 511080
Product code: JOH Tube Tracheostomy And Tube Cuff
Reason for recall: Lid tray incorrectly labeled as Tube I.D. 7.0 mm instead of correct size 8.0 mm
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Smiths Medical contacted dealers via telephone on December 12, 2003. The direct customers to whom product was shipped contacted via a visit by the Smiths Medical sales representative Monday, December 15, 2003 through December 12,2 003.
Quantity in commerce: 30 CASES (2/CASE)
Distribution: AZ, CA, CO, CT, FL, GA, IN, MA, NJ, NY, TN, TX, WI
Product codes and lots: Lot Number: K223373

Product code JOH

K980466Class IIPer-Fit Percutaneous Dilational Tracheostomy Kit with Specialty Tracheostomy Tube and Disposable Inner CannulaSims Portex, Inc. / cleared 1998-02-24

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)