BEUDAMED
    FDA Recall Terminated

    Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105.

    Recall: Z-0068-04 · Initiated August 28, 2002

    Recall

    Recall Number
    Z-0068-04
    Event Number
    27445
    Firm
    Wilson-Cook Medical Inc
    FEI Number
    1037905
    Product Code
    GCA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    August 28, 2002
    Posted
    October 24, 2003
    Terminated
    November 25, 2003
    Address
    4900 Bethania Station Rd, &, Winston-Salem, NC, 27105

    Description

    Howell D.A.S.H. Extraction Balloon, DASH-8.5-12-15, with Multiple Sizing, Catheter: 6 FR./200 CM. , Shelf Life: 1 Year, Sterile, Disposable, Single Use Only, Wilson-Cook Medical, 4900 Bethania Station Road, Winston-Salem, NC 27105.

    Reason

    The product was labeled with a 5 year expiration date instead of a 1 year expiration date.

    Action

    Field Representatives were notified via Fax or E-mail in August/September, 2002. After being notified about the recall, field representatives were responsible for notifying facilities about the market withdrawal and for furnishing instructions for returning products for credit.

    Distribution

    Nationwide; Argentina, Australia, Barbados, Bolivia, WI, Brazil, Canada, Costa Rica, Central Hong Kong, Colombia, Ecuador, El Salvador, England, Egypt, Guatemala, India, Indonesia, Ireland, Israel, Japan, Korea, Malaysia, Mexico, New Zealand, Pakistan, Philippines, Peoples Republic of China, Poland, Republic of Panama, Romania, Saudi Arabia, Singapore, Sri Lanka, Syria, Taiwan, Thailand, United Arab Emirates, Venezuela, Uruguay.

    Quantity

    2062 units