Class 2 Device Recall Cannon Catheter" II,

• Date Initiated by Firm: June 10, 2008
• Date Posted: September 17, 2008
• Recall Status: Terminated on December 03, 2009
• Recall Number: Z-2248-2008
• Recall Event ID: 48706
• 510(K)Number: K022662
• Product Classification: Catheter - Product Code MSD
• Product: Cannon Catheter" II, Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CSD-15282, 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.
• Code Information: Lot# RL5111237, RL5111325, and RF5061636
• Recalling Firm/ Manufacturer: Arrow International Inc; 2400 Bernville Rd; Reading PA 19605-9607
• For Additional Information Contact: Jody Cadd; 610-378-0131 Ext. 3318
• Manufacturer Reason for Recall: The tips may not have been adequately welded to the catheter body.
• FDA Determined Cause: Device Design
• 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.
• Quantity in Commerce: 79248 units (total for all catheters listed)
• 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
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = MSD