Z-0318-2007

Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S

Name: Z-0318-2007 Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
Creator: Edwards Lifesciences Corporation of Puerto Rico
Published: 2006-11-02
License: https://open.fda.gov/license/

Edwards Lifesciences Technology SARL / initiated 2006-11-02 / Terminated / root cause: packaging

FDA source

Edwards Lifesciences Corporation of Puerto Rico began a recall of Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S on 2006-11-02. The reason FDA records is "Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as packaging.

Recall record

Recall number: Z-0318-2007
Status: Terminated
Initiated: 2006-11-02
Posted: 2006-12-29
Terminated: 2012-02-07
Recalling firm: Edwards Lifesciences Technology SARL
Product: Edwards Lifesciences VANTEX Central Venous Catheter Set with OLIGON-Model A2720S
Product code: FOZ Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
Reason for recall: Lack of Assurance of Sterility-Device packaging was manufactured with an incorrect lid that could compromise the sterility of the product.
Root cause tag: packaging
FDA 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 in commerce: 55 units domestically , 80 units internationally and 50 units are in Edwards Lifescience control
Distribution: 1 Domestic and 1 Foreign
Product codes and lots: Model A2720S Lot Numbers: 946DC131, 946DC239 and 946FC460

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)