Z-1168-2007

Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number...

Name: Z-1168-2007 Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number...
Creator: Vance Products Incorporated
Published: 2007-06-29
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2007-06-29 / Terminated

FDA source

Vance Products Incorporated began a recall of Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724 on 2007-06-29. The reason FDA records is "The radiographic band may detach from the stent and remain in the patient after removal of the stent". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-1168-2007
Status: Terminated
Initiated: 2007-06-29
Posted: 2015-06-25
Terminated: 2008-06-11
Recalling firm: Cook Incorporated
Product: Cook Urological Black Silicone Filiform Double Pigtail Ureteral Stent Set, 7.0Fr/24cm, sterile, Order Number (REF) 133724.
Product code: FAD Stent, Ureteral
Reason for recall: The radiographic band may detach from the stent and remain in the patient after removal of the stent.
FDA root cause: Other
Action: Consignees were notified of the recall via letter dated 6//29/07, which instructed them to quarantine stock on hand and to fax number on hand back to Cook for return authorization.
Quantity in commerce: 75
Distribution: Worldwide, including USA, Canada, and Japan.
Product codes and lots: Lots U1629501, U1629502 and U1631782.

Product code FAD

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)