Recall Z-0272-04 ยท FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Edwards Lifesciences Corporation of Puerto Rico
Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA
| Date | Dec 24, 2003 (initiated Oct 8, 2003) |
| Status | Terminated |
| Reason | Lot is being recalled because some of the kits contain an incorrect guidewire. |
| Root cause | Other |
| Action | Customers were contacted by their Edwards Sales Representatives on 10/8/03. The Sales Representatives requested that all units be returned. |
| Quantity | 315 units |
| Distribution | Distribution was to hospitals (2) in MD and DC. |
| 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 |