BEUDAMED
    FDA Recall Terminated

    Arrow Percutaneous Sheath Introducers

    Recall: Z-1493-2009 · Initiated February 11, 2009

    Recall

    Recall Number
    Z-1493-2009
    Event Number
    51887
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    KGZ
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 11, 2009
    Posted
    June 24, 2009
    Terminated
    July 22, 2010
    Address
    2400 Bernville Road, Reading, PA, 19605

    Description

    Arrow Percutaneous Sheath Introducers

    Reason

    Leakage: Material not lipid resistant, may crack and/or leak. Use of this device with lipid containing solutions or 70% isopropyl alcohol may cause leakage or air embolism.

    Action

    Arrow International issued a letter dated 2/18/09 to all customers informing them of the problem and if a lipid resistant stopcock is required to contact the firm for replacements. New labels state: Warning - do not use with lipid containing solutions or 70% isopropyl alcohol, as these solutions may cause leakage or air embolism.

    Distribution

    Worldwide distribution: USA, Argentina, Australia, Bahamas, Belarus, Belgium, Brazil, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, Iceland, India, Indonesia, Ireland, Israel, Italy, Japan, Latvia, Lithuania, Malaysia, Mexico, Netherlands, New Zealand, Norway, Pakistan, Peru, Philippines, Poland, Singapore, Slovakia, South Africa, South Korea, Spain, Sri lanka, Sweden, Taiwan, Thailand, Tunisia, Turkey, UK, Ukraine, and Venezuela.

    Quantity

    900,000 total, all products