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Terminated

Quantum TTC Biliary Balloon Dilator

FDA Recall Z-1292-03 · Posted 2003-10-15

Recalling FirmWilson-Cook Medical Inc
Recall StatusTerminated
Product CodeKNQ
Date Initiated2003-09-15
Date Terminated2004-04-08
Product Quantity127 devices

Reason for Recall

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

Firm 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.

Root Cause

Other

Distribution Pattern

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,

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K935094BALLOON DILATION CATHETERWilson-Cook Medical, Inc. · 1995-01-24

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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