BEUDAMED
    FDA Recall Terminated

    ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA The product is used for long term hemodialysis vascular access.

    Recall: Z-2271-2008 · Initiated June 10, 2008

    Recall

    Recall Number
    Z-2271-2008
    Event Number
    48706
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    MSD
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 10, 2008
    Posted
    September 17, 2008
    Terminated
    December 3, 2009
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607

    Description

    ARROW Edge Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-IM, Intended for single use only, Sterile, Rx only, Arrow International, Inc., 2400 Bernville Road, Reading, PA 19605, USA The product is used for long term hemodialysis vascular access.

    Reason

    The tips may not have been adequately welded to the catheter body.

    Action

    Consignees were notified by letter on/about 06/10/2008. They were instructed to: 1. Cease use and distribution and quarantine all affected product immediately. 2. Contact Arrows Customer Service Department for a Return Authorization Number, enter the number on an enclosed Recall Acknowledgement & Stock Status Form and 3. Immediately fax back the form to Arrow International. All affected product is to be returned to Arrow International. A letter containing the recall information was enclosed for physicians who have implanted catheters. Contact Arrow's Customer Service at 1-800-523-8446 for assistance.

    Distribution

    U.S. Nationwide, Albania, Argentina, Australia, Belgium, Brazil, Canada , Chile, Colombia, Cyprus, Czech Republic, Dominican Republic, Ecuador, Finland, France, Germany, Greece, Guatemala, Hungary, India, Italy, Latvia, Liechtenstein, Lithuania, Mexico, Netherlands, New Zealand, Pakistan, Poland, Slovakia, South Africa, South Korea, Spain, Sweden, Taiwan, Tanzania, Turkey, UK and the Ukraine

    Quantity

    79248 units (total for all catheters listed)