Z-0338-2007

Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An...

Name: Z-0338-2007 Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An...
Creator: Edwards Lifesciences Technology SARL
Published: 2006-11-27
License: https://open.fda.gov/license/

Edwards Lifesciences Technology SARL / initiated 2006-11-27 / Terminated / root cause: labeling and UDI

FDA source

Edwards Lifesciences Technology SARL began a recall of Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75 on 2006-11-27. The reason FDA records is "Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which...". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0338-2007
Status: Terminated
Initiated: 2006-11-27
Posted: 2007-01-05
Terminated: 2012-01-23
Recalling firm: Edwards Lifesciences Technology SARL
Product: Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75
Product code: DYG Catheter, Flow Directed
Reason for recall: Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on the edge label . The edge label states the model is 831F75 which incorrectly indicates that product does NOT contain an antimicrobial heparin coating. (The tray lid label correctly states the model is 831HF75, containing the heparin coating)
Root cause tag: labeling and UDI
FDA root cause: Other
Action: Edwards initiated the recall in the US by sending a Customer Letter by Federal Express on November 28, 2006, along with a Q&A to their customers Service and Direct Customers to facilitate the uderstanding of the recall and the request for verification and return of all unused product.
Quantity in commerce: 1,110 units
Distribution: Worldwide Distribution ----USA and countries of Columbia and Venezuela.
Product codes and lots: Model Number: 831FH75 Lot Number: 246HC197 Expiration Date: Feb. 2008

Product code DYG

K812563Class IISwan-Ganz & Edslab Heparin Coated Cath.American Edwards Laboratories / cleared 1981-09-25

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)