BEUDAMED
    FDA Recall Terminated

    AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.

    Recall: Z-0591-2008 · Initiated November 13, 2007

    Recall

    Recall Number
    Z-0591-2008
    Event Number
    46149
    Firm
    AngioScore Inc.
    FEI Number
    3005462046
    Product Code
    NWX
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 13, 2007
    Posted
    January 23, 2008
    Terminated
    March 25, 2008
    Address
    5055 Brandin Ct, Fremont, CA, 94538-3140

    Description

    AngioSculpt PTCA Scoring Balloon Catheter, Catalog (REF) Number: 2027-2510, size 2.5mm x 10 mm, AngioScore, Inc., Fremont, CA.

    Reason

    Mis-labeling: Product labeling on product pouch indicates wrong size, the correct size is on the product carton

    Action

    The firm initiated a field correction and issued Medical Device Field correction letters to its consignees on 11/09/2007, instructing consignees to review their inventory and return any mislabeled product or contact the firm.

    Distribution

    Nationwide-to 30 medical facilities in NC, SC, OH, IL, NY, PA, NJ, PA, LA, KS, FL, WI, MI, WA, and CA.

    Quantity

    40 units