Cannon" II Plus, Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242-SP, 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.
FDA Recall Z-2252-2008 · Posted 2008-09-17
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Recalling FirmArrow International Inc
Recall StatusTerminated
Product CodeMSD
Date Initiated2008-06-10
Date Terminated2009-12-03
Product Quantity79248 units (total for all catheters listed)
Reason for Recall
The tips may not have been adequately welded to the catheter body.
Firm 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.
Root Cause
Device Design
Distribution Pattern
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
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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