Recall Z-0013-2009 ยท MJN Catheter, Intravascular Occluding, Temporary
Edwards Lifesciences, LLC
Edwards Lifesciences***Fogarty Fortis***Arterial Embolectomy Catheter Is indicated for the removal of fresh, soft emboli and thrombi from the vessels in the arterial system.
| Date | Oct 3, 2008 (initiated Jun 23, 2008) |
| Status | Terminated |
| Reason | Potential for tubing fracture near the tip of the catheter. |
| Root cause | Process control |
| Action | The firm sent Urgent Field Safety Notices dated June 23, 2008 to customers. The letter gave details on affected products, a description of the problem, and advise on action to be taken. Edwards has decided to recall these lots of Fogarty Fortis catheters which were manufactured between 9 June 2007 and 20 June 2008. The expiration date for these lots is between 11 September 2009 and 26 September 2009. The attached sheet lists product by model and lot number which you have ordered during that time frame. Please stop using these lots of catheter products immediately. Edwards requests that you |
| Quantity | 2,975 units |
| Distribution | International Distribution --- including countries of Austria, Belgium, Bulgaria, Switzerland, Czech republic, Germany, Denmark, United Kingdom, Italy, Luxembourg, Netherlands, Sweden, Slovak Republic, South Africa, and Taiwan. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.