Quantum TTC Biliary Balloon Dilator
- Company
- Wilson-Cook Medical Inc
- Recall Initiated
- September 15, 2003
- Posted
- October 15, 2003
- Terminated
- April 8, 2004
- Recall Number
- Z-1292-03
- Quantity
- 127 devices
- Firm Location
- Winston-Salem, NC
Reason for Recall
The product was labeled 'esophageal', but contained a 'biliary' ballon
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,
Lot / Code Info
W1790782, W1786043, W1783537, W1782956, W1782310, W1781860, W1777960, W1777449
Root Cause
Other
Action Taken
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.
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