FDA Device

Quantum TTC Biliary Balloon Dilator

Hazard

The product was labeled 'esophageal', but contained a 'biliary' ballon

What You Should Do

Remedy

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.

Products

Quantum TTC Biliary Balloon Dilator
Brand
Wilson-Cook Medical Inc
UPC
W1790782, W1786043, W1783537, W1782956, W1782310, W1781860, W1777960, W1777449

Units Affected

127 devices