Z-0721-2007

Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model...

Name: Z-0721-2007 Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model...
Creator: Urologix, Inc.
Published: 2007-03-16
License: https://open.fda.gov/license/

Urologix, LLC / initiated 2007-03-16 / Terminated / root cause: labeling and UDI

FDA source

Urologix, Inc. began a recall of Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model TA1321D on 2007-03-16. The reason FDA records is "The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing". 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-0721-2007
Status: Terminated
Initiated: 2007-03-16
Posted: 2007-04-05
Terminated: 2007-05-25
Recalling firm: Urologix, LLC
Product: Urologix Microwave Delivery System 2.5 - 3.5 For use with prostatic urethra lengths of 2.5-3.5 cm only. Model TA1321D.
Product code: MEQ System, Hyperthermia, Rf/Microwave (Benign Prostatic Hyperplasia),Thermotherapy
Reason for recall: The catheter in the kit matches the description on the kit and pouch label; however, an incorrect label was placed onto the catheter during manufacturing.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: A letter dated 3/16/07 was FedEx overnight to consignees. The letter described the product, problem and gave instructions for returning and replacing the affected product.
Quantity in commerce: 21
Distribution: Nationwide and the Netherlands.
Product codes and lots: Individual catheter lot number KG001346 for model TA1321D. Kit box lot number KGP111105.

Product code MEQ

The FDA recall record names no cleared device, and no clearance has been matched to it.

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)