Recall Z-2271-2008 ยท MSD Catheter, Hemodialysis, Implanted
Arrow International Inc
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.
| Date | Sep 17, 2008 (initiated Jun 10, 2008) |
| Status | Terminated |
| Reason | The tips may not have been adequately welded to the catheter body. |
| Root 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 ass |
| Quantity | 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, Sl |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040260 | INTEGRAL HEMODIALYSIS CATHETER Arrow Int'L., Mar 5, 2004 |