Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
FDA device recall Z-0318-2007 · posted 2006-12-29 · Terminated
Recall details
- Recalling firm
- Edwards Lifesciences Corporation of Puerto Rico
- Reason for recall
- Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- FOZ
- Quantity affected
- 55 units domestically , 80 units internationally and 50 units are in Edwards Lifescience control
- Distribution
- 1 Domestic and 1 Foreign
- Date initiated
- 2006-11-02
- Date posted
- 2006-12-29
- Date terminated
- 2012-02-07
- 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 |