Z-0520-2007

Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road...

Name: Z-0520-2007 Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road...
Creator: Cook Endoscopy
Published: 2007-01-24
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2007-01-24 / Terminated / root cause: labeling and UDI

FDA source

Cook Endoscopy began a recall of Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105 on 2007-01-24. The reason FDA records is "The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR". 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-0520-2007
Status: Terminated
Initiated: 2007-01-24
Posted: 2007-02-22
Terminated: 2012-07-26
Recalling firm: Wilson-Cook Medical Inc.
Product: Quantum TTC Biliary Balloon Dilation Catheter, Wilson Cook Medical, GI Endoscopy, 4900 Bethania Station Road, Winston-Salem, NC 27105
Product code: KNQ Dilator, Esophageal
Reason for recall: The graphic label is incorrect, it lists 6mm/ 18FR. The product label is correct, it lists 10mm/ 30FR.
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Consignees were notified by UPS certified mail and email on/about 01/31/2007. They were instructed to return any affected product to Cook Endoscopy. A response form was attached to be completed and returned to Cook Endoscopy.
Quantity in commerce: 12 units
Distribution: Worldwide, including NY and TX in USA, Australia, Canada and India.
Product codes and lots: Order number QBD-10X3, Lot number W2287708

Product code KNQ

K935094Class IIBalloon Dilation CatheterWilson-Cook Medical, Inc. / cleared 1995-01-24

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)