Z-0966-2011

Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050

Name: Z-0966-2011 Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050
Creator: Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN
Published: 2010-12-13
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2010-12-13 / Terminated / root cause: packaging

FDA source

Vance Products Inc. dba Cook Urological Inc. & Cook OB/GYN began a recall of Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050 on 2010-12-13. The reason FDA records is "The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0966-2011
Status: Terminated
Initiated: 2010-12-13
Posted: 2011-01-25
Terminated: 2011-01-31
Recalling firm: Cook Incorporated
Product: Cook Urological, Inc. Koyle Diaper Stent 6.0 Fr, Sterile, GPN G17667, REF KDSCF-060050.
Product code: KOD Catheter, Urological
Reason for recall: The firm received a complaint that 15 units of the Koyle Diaper Stent were received in packages that had not been sealed. Each stent should be sealed in a poly-Tyvek pouch.
Root cause tag: packaging
FDA root cause: Packaging process control
Action: The firm sent an URGENT RECALL NOTICE to one consignee on 12/13/2010 (the other consignee returned all their product as a complaint). The letter informed the consignee of the recall and asked the customer to return the recalled product.
Quantity in commerce: 25 stents
Distribution: CA, CT
Product codes and lots: U1973244

Product code KOD

K820313Class IIVpi-Fair Urethral StentVance Products, Inc. / cleared 1982-03-01

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)