Edwards Lifesciences Technology SARL Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75 Recall
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thromboshield (An Antimicrobial*Heparin Coating), REF:831HF75
Brand
Edwards Lifesciences Technology SARL
Lot Codes / Batch Numbers
Model Number: 831FH75 Lot Number: 246HC197 Expiration Date: Feb. 2008
Products Sold
Model Number: 831FH75 Lot Number: 246HC197 Expiration Date: Feb. 2008
Edwards Lifesciences Technology SARL is recalling Edwards Lifesciences-Swan-Ganz,Thermodilution Venous Infusion Port (VIP) Catheter with AMC Thrombosh due to Misbranding-One lot of Swan-Ganz Thermodilution VIP Catheters, Model 831HF75, lot 246HC197 was labeled with different model information (831F75) on th. Based on FDA medical device recall database.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
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)
Recommended Action
Per FDA guidance
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.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026