Z-1162-2007

Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm...

Name: Z-1162-2007 Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm...
Creator: Cook Urological, Inc.
Published: 2007-06-12
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2007-06-12 / Terminated / root cause: manufacturing process

FDA source

Cook Urological, Inc. began a recall of Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413 on 2007-06-12. The reason FDA records is "Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed". 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-1162-2007
Status: Terminated
Initiated: 2007-06-12
Posted: 2007-08-09
Terminated: 2009-11-25
Recalling firm: Cook Incorporated
Product: Cook PTFE Wire Guide with 3 cm flexible tip, to establish a tract for ureteral/renal access, .038", 145 cm; sterile; Order/Ref number 638413.
Product code: EZB Stylet For Catheter, Gastro-Urology
Reason for recall: Lack of assurance of sterility, in that the product is labeled as sterile but the package may not have been sealed.
Root cause tag: manufacturing process
FDA root cause: Process control
Action: Consignees were notified via letter dated 6/12/07 and instructed to cease using the product and to inform the firm if they have product to return.
Quantity in commerce: 100
Distribution: Nationwide and Canada.
Product codes and lots: Lot U1621121

Product code EZB

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)