FDA Medical Device Recalls (openFDA)
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
- Recall number
- Z-0272-04
- Recalling firm
- Edwards Lifesciences Corporation of Puerto Rico
- Product
- Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA
- Status
- Terminated
- Initiated
- 2003-10-08
- Posted
- 2003-12-24
- Terminated
- 2004-02-09
- 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.
- Lot, serial or model codes
- Lot no. 973H0589 Exp. date 2/2005
- 510(k) numbers
- ["K992532"]
- PMA numbers
- not on file
- Product code
- FOZ
- Firm FEI
- 2648045
- Firm city
- Anasco
- Firm state
- not on file
- Firm country
- PR
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