Z-0272-04

Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards...

Name: Z-0272-04 Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards...
Creator: Edwards Lifesciences Corporation of Puerto Rico
Published: 2003-10-08
License: https://open.fda.gov/license/

Edwards Lifesciences Technology SARL / initiated 2003-10-08 / Terminated

FDA source

Edwards Lifesciences Corporation of Puerto Rico began a recall of Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA on 2003-10-08. The reason FDA records is "Lot is being recalled because some of the kits contain an incorrect guidewire". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-0272-04
Status: Terminated
Initiated: 2003-10-08
Posted: 2003-12-24
Terminated: 2004-02-09
Recalling firm: Edwards Lifesciences Technology SARL
Product: Edwards Lifesciences Vantex Central Venous Catheter Kit with Oligon, Ref/model #: 3K20C1827, Rx only, Edwards Lifesciences LLC, Irvine, CA 96214-5686 USA
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Lot is being recalled because some of the kits contain an incorrect guidewire.
FDA 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 in commerce: 315 units
Distribution: Distribution was to hospitals (2) in MD and DC.
Product codes and lots: Lot no. 973H0589 Exp. date 2/2005

Product code FOZ

K992532Class IIVantex Central Venous Catheter with Oligon Material with or without Amc Thromboshield CoatingBaxter Healthcare Corp / cleared 2000-06-13

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)