Z-0980-2009

Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook...

Name: Z-0980-2009 Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook...
Creator: Vance Products Incorporated
Published: 2008-11-10
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2008-11-10 / Terminated / root cause: labeling and UDI

FDA source

Vance Products Incorporated began a recall of Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN... on 2008-11-10. The reason FDA records is ""Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent...". 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-0980-2009
Status: Terminated
Initiated: 2008-11-10
Posted: 2009-02-10
Terminated: 2009-11-25
Recalling firm: Cook Incorporated
Product: Cook Medical Universa Soft Ureteral Stent and Positioner with Hydrophilic Coating, 5.0Fr/26cm, sterile, Cook Urological Inc., Spencer, IN; REF USH-526-R, GPN REF G49966. The product was placed in a shipping box which is preprinted with the word "firm" instead of "soft", but a product specific label stating "soft", as above, was also placed on the box. The ureteral stent is used for temporary drainage from the ureteropelvic junction to the bladder.
Product code: FAD Stent, Ureteral
Reason for recall: "Soft" stents were placed in "firm" stent outer boxes. The soft stent is only to be left in the patient for 6 months, but the firm stent can be left in the patient for 12 months, so this error could result in the stent being left in the patient for longer than indicated for the device.
Root cause tag: labeling and UDI
FDA root cause: Labeling mix-ups
Action: Consignees were notified via recall letter, "Urgent: Recall Notice" dated November 10, 2008, and by follow-up phone call. Customers were instructed to isolate the recalled product, complete the enclosed form and fax to Cook Urological at 812-829-2353. After receipt of the completed form, Cook Urological will issue a Return Goods Authorization number for each customer to return the affected product to Cook Urological via FedEx or UPS.
Quantity in commerce: 23
Distribution: Nationwide Distribution including states of Georgia, Oregon and Texas.
Product codes and lots: Lot Number: U1753668.

Product code FAD

K961446Class IIAq Hydrophilic StentCook Urological, Inc. / cleared 1996-05-28

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 2026-10-07, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)