FDA Medical Device Recalls (openFDA)
Edwards Lifesciences Corporation of Puerto Rico: Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
- Recall number
- Z-0318-2007
- Recalling firm
- Edwards Lifesciences Corporation of Puerto Rico
- Product
- Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
- Status
- Terminated
- Initiated
- 2006-11-02
- Posted
- 2006-12-29
- Terminated
- 2012-02-07
- 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
- Lot, serial or model codes
- Model A2720S Lot Numbers: 946DC131, 946DC239 and 946FC460
- 510(k) numbers
- ["K992532"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 2648045
- Firm city
- Anasco
- Firm state
- PR
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28