BEUDAMED
    FDA Recall Terminated

    Quantum TTC Biliary Balloon Dilator

    Recall: Z-1292-03 · Initiated September 15, 2003

    Recall

    Recall Number
    Z-1292-03
    Event Number
    27261
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    KNQ
    Status
    Terminated
    Root Cause
    Other
    Initiated
    September 15, 2003
    Posted
    October 15, 2003
    Terminated
    April 8, 2004
    Address
    4900 Bethania Station Rd, &, Winston-Salem, NC, 27105

    Description

    Quantum TTC Biliary Balloon Dilator

    Reason

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

    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.

    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,

    Quantity

    127 devices