Z-1292-03

Quantum TTC Biliary Balloon Dilator

Name: Z-1292-03 Quantum TTC Biliary Balloon Dilator
Creator: Wilson-Cook Medical Inc
Published: 2003-09-15
License: https://open.fda.gov/license/

Wilson-Cook Medical Inc. / initiated 2003-09-15 / Terminated / root cause: labeling and UDI

FDA source

Wilson-Cook Medical Inc began a recall of Quantum TTC Biliary Balloon Dilator on 2003-09-15. The reason FDA records is "The product was labeled 'esophageal', but contained a 'biliary' ballon". 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-1292-03
Status: Terminated
Initiated: 2003-09-15
Posted: 2003-10-15
Terminated: 2004-04-08
Recalling firm: Wilson-Cook Medical Inc.
Product: Quantum TTC Biliary Balloon Dilator
Product code: KNQ Dilator, Esophageal
Reason for recall: The product was labeled 'esophageal', but contained a 'biliary' ballon
Root cause tag: labeling and UDI
FDA root cause: Other
Action: The consignees were notified of the recall via letter on September 15, 2003. The bottom portion of the recall communication is to be returned indicating amount of product being returned or indicating no product was to be returned.
Quantity in commerce: 127 devices
Distribution: Nationwide. CA, FL, IL, IN, IA, KS, LA, MI, MO, NJ, NC, OH, OK, TX, VA, WA, WI and foreign accounts in Canada, England, India, Japan, Korea, Mexico and Uruguary,
Product codes and lots: W1790782, W1786043, W1783537, W1782956, W1782310, W1781860, W1777960, W1777449

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)