Recall Z-0318-2007 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Edwards Lifesciences Corporation of Puerto Rico
Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
| Date | Dec 29, 2006 (initiated Nov 2, 2006) |
| Status | Terminated |
| Reason | Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product. |
| Root cause | Other |
| Action | Edwards initiated the recall in the US by sending a voicemail on November 2, 2006, to their sale representative requesting of all unused product from one domestic customer. The Sale representative was provided with a recall letter for the cutomer to facilitate notification. Edwards requested that either the customer or the Sale Representative provide written verification of stock and identify any unused product to be returned . This will allow Edwards to track the effectiveness of this recall. Their Eurpoe operations initiated a similar recall plan in Europe on November 2, 2006. |
| Quantity | 55 units domestically , 80 units internationally and 50 units are in Edwards Lifescience control |
| Distribution | 1 Domestic and 1 Foreign |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K992532 | VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING Baxter Healthcare Corp, Jun 13, 2000 |