Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifescienc
FDA device recall Z-0272-04 · posted 2003-12-24 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Corporation of Puerto Rico
- Reason for recall
- Lot is being recalled because some of the kits contain an incorrect guidewire.
- Action taken
- Customers were contacted by their Edwards Sales Representatives on 10/8/03. The Sales Representatives requested that all units be returned.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 315 units
- Distribution
- Distribution was to hospitals (2) in MD and DC.
- Date initiated
- 2003-10-08
- Date posted
- 2003-12-24
- Date terminated
- 2004-02-09
- Location
- Anasco, PR
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| VANTEX CENTRAL VENOUS CATHETER WITH OLIGON MATERIAL WITH OR WITHOUT AMC THROMBOSHIELD COATING (K992532) | Baxter Healthcare Corp | 2000-06-13 |