Z-0554-03

Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0

Name: Z-0554-03 Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0
Creator: Cook Urological, Inc.
Published: 2003-01-22
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2003-01-22 / Terminated / root cause: labeling and UDI

FDA source

Cook Urological, Inc. began a recall of Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0 on 2003-01-22. The reason FDA records is "Product is labeled sterile, but was not sterilized". 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-0554-03
Status: Terminated
Initiated: 2003-01-22
Posted: 2003-02-13
Terminated: 2003-03-26
Recalling firm: Cook Incorporated
Product: Pursuit ureteral dilation balloon catheters, 6 mm x 4 cm. Order # PAB-050080-6-4.0
Product code: EZN Dilator, Catheter, Ureteral
Reason for recall: Product is labeled sterile, but was not sterilized.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Customers were notified by phone call and recall letter beginning on 1/22/03.
Quantity in commerce: 15
Distribution: Alaska, Hawaii, Minnesota, Ohio, Tennessee and Ireland.
Product codes and lots: Lot 1049345

Product code EZN

K990072Class IIBalloon Ureteral Dilators, Accent Dg Balloon Ureteral Dilator Set, Ascend Balloon Dilation Catheters, Balloon Dilation CCook Urological, Inc. / cleared 1999-03-25

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)